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Nexpine
EUDAMEDClass IIb (EU MDR)
Ref BS103.65.35Model 5.5 mm Mono Axial Pedicle ScrewRef BS105.55.50Ref BS106.65.55Ref BS134.70.65Ref BS106.65.65Ref BS106.65.45Ref BS101.45.25Ref BS106.65.85Ref BS134.70.45Ref BS104.45.45Ref BS102.55.45Ref BS102.55.40Ref BS106.65.30Ref BS106.65.80Ref BS106.65.40Ref BS101.45.40Ref BS134.70.60Ref BS134.70.55Ref BS101.45.35Ref BS101.45.45Ref BS134.70.35
Identity
- Trade Name
- NEXPINE EUDAMED
- Device Name
- Spinal Implants EUDAMED
- Model / Reference
- 5.5 mm Mono Axial Pedicle Screw EUDAMEDBS103.65.35 EUDAMEDBS105.55.50 EUDAMEDBS106.65.55 EUDAMEDBS134.70.65 EUDAMEDBS106.65.65 EUDAMEDBS106.65.45 EUDAMEDBS101.45.25 EUDAMEDBS106.65.85 EUDAMEDBS134.70.45 EUDAMEDBS104.45.45 EUDAMEDBS102.55.45 EUDAMEDBS102.55.40 EUDAMEDBS106.65.30 EUDAMEDBS106.65.80 EUDAMEDBS106.65.40 EUDAMEDBS101.45.40 EUDAMEDBS134.70.60 EUDAMEDBS134.70.55 EUDAMEDBS101.45.35 EUDAMEDBS101.45.45 EUDAMEDBS134.70.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BS10365350 EUDAMEDG562BS10555500 EUDAMEDG562BS10665550 EUDAMEDG562BS13470650 EUDAMEDG562BS10665650 EUDAMEDG562BS10665450 EUDAMEDBS10145250 EUDAMEDG562BS10665850 EUDAMEDG562BS13470450 EUDAMEDG562BS10445450 EUDAMEDG562BS10255450 EUDAMEDG562BS10255400 EUDAMEDG562BS10665300 EUDAMEDG562BS10665800 EUDAMEDG562BS10665400 EUDAMEDG562BS10145400 EUDAMEDG562BS13470600 EUDAMEDG562BS13470550 EUDAMEDG562BS10145350 EUDAMEDG562BS10145450 EUDAMEDG562BS13470350 EUDAMED
- Basic UDI-DI
- ++G562SPD7 EUDAMED
- Direct Marketing DI
- G562BS10365350 EUDAMEDG562BS10555500 EUDAMEDG562BS10665550 EUDAMEDG562BS13470650 EUDAMEDG562BS10665650 EUDAMEDG562BS10665450 EUDAMEDG562BS10665850 EUDAMEDG562BS13470450 EUDAMEDG562BS10445450 EUDAMEDG562BS10255450 EUDAMEDG562BS10255400 EUDAMEDG562BS10665300 EUDAMEDG562BS10665800 EUDAMEDG562BS10665400 EUDAMEDG562BS10145400 EUDAMEDG562BS13470600 EUDAMEDG562BS13470550 EUDAMEDG562BS10145350 EUDAMEDG562BS10145450 EUDAMEDG562BS13470350 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 (21)
- EUDAMED a7033d38-f2c5-43f0-b90e-2339a534f002 61 fields · synced Aug 3, 2026
- EUDAMED ef876790-1a6a-411c-ba31-653594c9d7e7 61 fields · synced May 16, 2026
- EUDAMED 7d5c05da-3228-4b1a-9121-6b8538ebe7f1 61 fields · synced May 17, 2026
- EUDAMED 4188a759-b1e5-4db8-b583-4e4341ec812d 61 fields · synced May 17, 2026
- EUDAMED 4054b47c-d41a-4ae0-a818-0e46d7dd17bb 61 fields · synced May 17, 2026
- EUDAMED bce72084-01d1-4488-8b83-a1f0fcfea779 61 fields · synced May 17, 2026
- EUDAMED 51fbb649-c70c-4c0f-b614-27b588e195f8 61 fields · synced May 17, 2026
- EUDAMED 5a8b0030-b1f2-452e-98cc-89b9b19c586b 61 fields · synced May 17, 2026
- EUDAMED 4a7c7fd4-4f18-4a86-a48c-0d6c4206def8 61 fields · synced May 17, 2026
- EUDAMED 9d7cb0fb-63fb-4ae5-91f3-acfcb9a59da3 61 fields · synced May 17, 2026
- EUDAMED bb27afc1-aff9-43cc-8e16-348e91399191 61 fields · synced May 17, 2026
- EUDAMED c6923a89-268c-40ec-b7c1-749dda6a8a96 61 fields · synced May 17, 2026
- EUDAMED 98f8d158-e34d-427b-91d5-b91eff65d0b1 61 fields · synced May 17, 2026
- EUDAMED 1e22a415-735b-4ec5-9bc7-b7ed6beb31f3 61 fields · synced May 18, 2026
- EUDAMED e5de71ae-f298-4d0d-bf3f-e457071a4c44 61 fields · synced May 18, 2026
- EUDAMED 60bd5021-65a0-4487-9f7b-ceed1f855ebb 61 fields · synced May 18, 2026
- EUDAMED 6fc41229-f80b-42f8-b852-6b6d4f9ebc51 61 fields · synced May 18, 2026
- EUDAMED a080305a-9b43-446b-8890-63eb683635fa 61 fields · synced May 19, 2026
- EUDAMED f2bec556-ee73-4529-9aa3-19204a1a3af3 61 fields · synced May 19, 2026
- EUDAMED 9e1c4e20-234c-4269-bff7-140bff1c4713 61 fields · synced May 19, 2026
- EUDAMED acd647d2-18fd-462d-a986-4e68ea542d7b 61 fields · synced May 19, 2026