Identity
- Trade Name
- Straight Stem Reamer , Ø14mm EUDAMED
- Model / Reference
- REAMERS EUDAMEDNMRKS164 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549533137 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
Straight Stem Reamer , Ø14mm by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular orthopaedic reamer.
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
- ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- M.B.T. — DePuy Ireland UC · Class IIa
- U2 Total Knee System — United Orthopedic Corporation · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (1)
- EUDAMED 136b458f-6111-4a87-ad67-0418dac19310 61 fields · synced Jun 19, 2026