Identity
- Trade Name
- Flexible Reamer Ø13 EUDAMED
- Model / Reference
- REAMERS EUDAMEDNM-16-115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549533243 EUDAMED
- Basic UDI-DI
- 86804870REA63 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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: Acetabular orthopaedic reamer
Flexible Reamer Ø13 by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Acetabular orthopaedic reamer.
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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 | 86804870REA63 | Class I | Active |
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Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (1)
- EUDAMED d677efca-170a-498f-9499-fcf1fe13a56f 61 fields · synced Jul 9, 2026