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TAMINA 3.5mm Proximal Humerus Plate, 9 Hole, Long, Right
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref B-122200Model TAMINA 3.5mm Proximal Humerus Plate
Identity
- Trade Name
- TAMINA 3.5mm Proximal Humerus Plate, 9 Hole, Long, Right EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- TAMINA EUDAMED
- Model / Reference
- TAMINA 3.5mm Proximal Humerus Plate EUDAMEDB-122200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461909 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746TAMINAKF EUDAMED
- Direct Marketing DI
- 07640187461909 EUDAMED
- 510(k) Number
- K231292 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
TAMINA 3.5mm Proximal Humerus Plate, 9 Hole, Long, Right by Bonebridge AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018746TAMINAKF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (2)
- EUDAMED a45a1eb4-813c-4129-9e37-4f2dd54847d7 61 fields · synced Jul 27, 2026
- FDA UDI 7f064d98-b9f9-4475-a040-e5a35cc38650 33 fields · synced May 30, 2026