Identity
- Device Name
- Sterile Adjustable Fixation Button EUDAMED
- Model / Reference
- NT.SP.T5601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970966198636 EUDAMED
- Basic UDI-DI
- B-06970966198636 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
Sterile Adjustable Fixation Button by Naton Biotechnology (Beijing) Co., Ltd. — 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-06970966198636 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Naton Biotechnology (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000018244
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED b8bf3d03-4f4b-4d22-8314-a57586a9e1fb 61 fields · synced Jun 18, 2026