Identity
- Trade Name
- REGULA NORMMED TITANIUM BUTTON / 55 mm EUDAMED
- Device Name
- REGULA NORMMED TITANIUM BUTTON / 55 mm EUDAMED
- Model / Reference
- NMKA0410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549593841 EUDAMED
- Basic UDI-DI
- B-08682549593841 EUDAMED
- EMDN Code
- H900301 SUTURE BUTTONS 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 TITANIUM BUTTON / 55 mm by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08682549593841 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (1)
- EUDAMED 20768703-8c56-4044-b4d2-86b59f0c8b01 61 fields · synced Jun 19, 2026