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Bonopty Penetration Set 14G, 6.5 cm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10-1062
by AprioMed AB
Identity
- Trade Name
- Bonopty Penetration Set 14G, 6.5 cm EUDAMEDBonopty Penetration Set FDA UDI
- Generic Name
- Bone biopsy needle FDA UDI
- Device Name
- Bonopty EUDAMEDManually operated, sterile, single use coaxial bone biopsy system. FDA UDI
- Model / Reference
- 10-1062 EUDAMEDG023 FDA UDI
- Description
- Manually operated, sterile, single use coaxial bone biopsy system. FDA UDI
Identifiers
- Catalog Number
- 10-1062 FDA UDI
- Primary DI / UDI-DI
- 07350031350234 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500313511KG EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- Bone biopsy needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDILength — 6.5 Centimeter FDA UDI
Bonopty Penetration Set 14G, 6.5 cm by Apriomed AB — Class IIa — 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 | 73500313511KG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AprioMed AB
- EUDAMED SRN
- SE-MF-000001013
Sources (2)
- EUDAMED d5d81a3e-c073-4bf4-9114-ba238bae2b1f 61 fields · synced Jul 31, 2026
- FDA UDI 172ef243-f05e-44c2-9344-63b335bed06d 36 fields · synced May 30, 2026