Identity
- Trade Name
- Mathieu Needle Holder 14cm Regular Tips EUDAMED
- Device Name
- Mathieu Needle Holder 14cm Regular Tips EUDAMED
- Model / Reference
- PI0465 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G796PI04650 EUDAMED
- Basic UDI-DI
- ++G796PI0465XK EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Suturing needle holder, reusable
Mathieu Needle Holder 14cm Regular Tips by Promed Instruments — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Mathieu Needle Holders
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G796PI0465XK | Class I | Active |
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Manufacturer
- Manufacturer
- Promed Instruments
- EUDAMED SRN
- PK-MF-000049405
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED f1f34077-461c-419a-811d-648f3707d85c 61 fields · synced Jul 16, 2026