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REGULA NORMMED PEEK INTERFERENCE SCREW/ 8X25 mm
EUDAMEDClass IIb (EU MDR)
Ref NMKA0704
Identity
- Trade Name
- REGULA NORMMED PEEK INTERFERENCE SCREW/ 8X25 mm EUDAMED
- Device Name
- REGULA NORMMED PEEK INTERFERENCE SCREW/ 8X25 mm EUDAMED
- Model / Reference
- NMKA0704 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549594015 EUDAMED
- Basic UDI-DI
- B-08682549594015 EUDAMED
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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: Tendon/ligament bone anchor, non-bioabsorbable
REGULA NORMMED PEEK INTERFERENCE SCREW/ 8X25 mm by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682549594015 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (1)
- EUDAMED 5b17717e-1d30-47af-9e8f-59c80bde8365 61 fields · synced Jun 18, 2026