33 injection machines, 22–600 t
Welltec, Haitian, Yizumi, Wittmann Battenfeld — built 2003–2021, 76% servo/hybrid. Newest: 2 × Wittmann SmartPower (2020/2021, UNILOG B8 control).
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Anitex Medical Components
Precision injection molding for medical device manufacturers.
Plastic components and sub-assemblies — manufactured to your specification, under your quality system. Your device. Our repeatability.
ISO 9001:2015FAI / PPAPNDA first
Our role
Component supplier. Not the device manufacturer.
We are a component supplier to medical device manufacturers. Device certification remains with the customer — our responsibility is a repeatable, documented, auditable production process: from DFM through FAI/PPAP to batch-level inspection.
Focus: housings and equipment components for reusable medical devices (no patient contact), technical parts with tolerances of ±0.05 mm on functional dimensions — proven by a CMM report at FAI — class-A surfaces, sub-assembly.
Evidence, not claims
A supplier that understands audits.
Automation
Part-removal robots and conveyors at the machines, gravimetric dosing (Maguire ULTRA 300), Shini mould temperature control.
In-house tool shop
CNC milling (Wemas VZ-1250, 2018), die-sinking EDM (GF AgieCharmilles FORM P 600, 2020; FORM 30), wire EDM (CUT 30 P), surface grinding (2022), CNC turning (Doosan LYNX 2100LMB). Build, maintenance and modification of moulds — including customer-owned tools.
Metrology
Measuring room, control plans and dimensional reports for every batch; full dimensional reports at FAI/PPAP.
Quality system
Documented. Traceable. Auditable.
- ISO 9001:2015 — certified quality management system; certificate available as PDF on request.
- Batch-level traceability: raw-material batch → product batch → shipment.
- Written change approval (change control): no change to material, process or mould without the customer's written approval.
- Documentation: FAI, PPAP/ISIR, CMM dimensional reports, CoC/CoA material certificates.
- IQ-OQ-PQ validation readiness to the customer's protocols.
- Open-door supplier audits — online or on site; slot usually within the week of the inquiry.
Medical roadmap
Facts and dates. Not ambitions.
- 1983
Technical injection moulding begins; today 33 machines 22–600 t and an in-house tool shop.
- ISO 9001
Certified QMS (ISO 9001:2015), certificate available for review.
- ISO 13485
Status & audit date — board decision, date to be added.
- Cleanroom ISO 8
Investment decision under evaluation — date to be added.
- First medical FAI
Target: published with the roadmap.
Materials
Engineering plastics. Medical grade on request.
We process engineering plastics for housings and equipment components: PC, PC/ABS, ABS, PP, PA6/PA66 (incl. glass-filled), POM, PBT, TPE/TPU. On request, medical-grade resins exclusively from qualified suppliers — with CoC/CoA certificate management. UL94 flammability class and disinfectant-resistant grades selected to your specification, based on supplier data.
PCPC/ABSABSPPPA6 / PA66 (+GF)POMPBTTPE / TPU
No ISO 10993 claims without testing: biocompatibility is demonstrated at your device level.
Why a new player
43 years of technical molding. Now to medical standards.
Straight talk: we don't have a medical portfolio yet — we have 43 years of process discipline in industrial projects with a comparable tolerance regime (child car seats, detonation connectors for mining), open capacity, and an investment roadmap with dates. Our first medical customer is not number thirty in the queue — they get priority capacity and direct board-level attention.
People
Names, not mailboxes.
Audit questions are answered in person — book a 30-minute online audit.
Natalia Piechowiak
Key Account Manager — DACH
DE · EN · PL
Nearshoring
An EU supply chain instead of Asia risk.
Production in Silesia (Poland), own fleet: Berlin ~6 h, Vienna ~5 h by truck. Short supply chains, same time zone, English/German-speaking project team, flexible batch sizes.
- Prague~5 htruck
- Vienna~5 htruck
- Berlin~6 htruck
- Munich~9 htruck
- Frankfurt~10 htruck
- Amsterdam~14 htruck
RFQ
Two paths. Both fast.
- 24hEngineer's first response
Feasibility in one working day.
- 72hQuote with DFM notes
Part price, tooling cost, cost-down suggestions.
- NDAConfidentiality first
We are happy to sign an NDA before you send documentation.
FAQ
Questions a medical buyer asks.
Do you have ISO 13485?
Not yet. We operate under ISO 9001:2015; the ISO 13485 status and audit date are part of our roadmap — the date will be published after the board decision. Until then we manufacture under your quality system, with FAI/PPAP and full documentation.
Do you have a cleanroom?
No. Our entry point is components that do not require cleanroom production — housings and parts of reusable equipment. The ISO 8 cleanroom decision will be published with a date in the roadmap after the investment decision.
Who certifies the device?
The customer. We supply components to your specification — with full documentation (FAI, PPAP/ISIR, dimensional reports, CoC/CoA).
Can I audit you?
Yes — online or on site; a slot usually within the week of the inquiry. A 30-minute online audit is the fastest way in.
How does your change control work?
No change to material, process or mould happens without the customer's written approval. Every proposed change is documented with an impact assessment for your sign-off. After approval we update the documentation and flag the first post-change batch.
Do you build tools?
Yes — an in-house tool shop (CNC milling, die-sinking and wire EDM, grinding, turning): new builds, maintenance, repairs and modifications, including customer-owned moulds.