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Nexpine
EUDAMEDClass IIb (EU MDR)
Ref BS103.65.50Model 5.5 mm Mono Axial Pedicle Screw
Identity
- Trade Name
- NEXPINE EUDAMED
- Device Name
- Spinal Implants EUDAMED
- Model / Reference
- 5.5 mm Mono Axial Pedicle Screw EUDAMEDBS103.65.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BS10365500 EUDAMED
- Basic UDI-DI
- ++G562SPD7 EUDAMED
- Direct Marketing DI
- G562BS10365500 EUDAMED
- EMDN Code
- P09070399 IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Nexpine by Bonetech Medisys Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G562SPD7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bonetech Medisys Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000020462
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 92658801-2c30-4f7b-a75e-c57c27271d21 61 fields · synced Jun 18, 2026