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Gillies Needle Holder 16cm (TC)
EUDAMEDClass I (EU MDR)
Ref 11-116
by AR Instrumed
Identity
- Trade Name
- Gillies Needle Holder 16cm (TC) EUDAMED
- Device Name
- Surgery Needle Holders EUDAMED
- Model / Reference
- 11-116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 42518911052682 EUDAMED
- Basic UDI-DI
- 4251891NEEDLEHOLDERS9M EUDAMED
- Direct Marketing DI
- 42518911052682 EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Gillies Needle Holder 16cm (TC) by AR Instrumed — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Suturing needle holder, reusable.
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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 | 4251891NEEDLEHOLDERS9M | Class I | Active |
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Manufacturer
- Manufacturer
- AR Instrumed
- EUDAMED SRN
- PK-MF-000019554
- Authorised Representative
- AR Instrumed Deutschland GmbH DE-AR-000014821
Sources (1)
- EUDAMED f9b5fb98-a315-4d87-a2a4-30a9843abb6c 61 fields · synced Aug 4, 2026