Identity
- Trade Name
- Bonopty Adapter EUDAMEDFDA UDI
- Generic Name
- Surgical instrument handle grip FDA UDI
- Device Name
- Bonopty Adapter 1:3 Revolutions EUDAMEDUniversal connector compatible with AprioMed Bonopty drills. FDA UDI
- Model / Reference
- 250 EUDAMEDG048 FDA UDI
- Description
- Universal connector compatible with AprioMed Bonopty drills. FDA UDI
Identifiers
- Catalog Number
- 250 FDA UDI
- Primary DI / UDI-DI
- 07350031350487 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500313518KW EUDAMED
- FDA Product Code
- HXY FDA UDI
- EMDN Code
- A018099 NEEDLES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument handle grip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
Bonopty Adapter by Apriomed AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73500313518KW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AprioMed AB
- EUDAMED SRN
- SE-MF-000001013
Sources (2)
- EUDAMED 57ed8141-28a2-4516-885f-cfb348ba1422 61 fields · synced Jul 26, 2026
- FDA UDI ce7d0382-8d5f-44bf-bb3f-f39d622c04f8 35 fields · synced May 30, 2026