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Bending Iron
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-430001Model Bonebridge Instrument-Ir
Identity
- Trade Name
- Bending Iron EUDAMEDFDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- Bonebridge Instrument-Ir EUDAMED
- Model / Reference
- Bonebridge Instrument-Ir EUDAMEDB-430001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461572 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsIrTM EUDAMED
- Direct Marketing DI
- 07640187461572 EUDAMED
- FDA Product Code
- HXP FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bending Iron by Bonebridge AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 764018746InstrumentsIrTM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (3)
- EUDAMED 1fba1869-a633-4697-9800-65565eac26fb 61 fields · synced Jun 19, 2026
- FDA UDI bae7ff1c-010f-4f56-a465-ec1db17add2d 32 fields · synced May 30, 2026
- EUDAMED 0d823b2d-99c7-40d6-aab5-a5b73b7c2b67 61 fields · synced Jun 19, 2026