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NEAL Pre-cut Splint SP
EUDAMEDClass I (EU MDR)
Ref NHPS-3036SModel NHRS, NHPS - F/G, SP, NWRef NHPS-3024SRef NHPS-6034SRef NHPS-4026SRef NHPS-2012SRef NHPS-4016S
by BL Tech
Identity
- Trade Name
- NEAL Pre-cut Splint SP EUDAMED
- Device Name
- NHRS, NHPS - F/G, SP, NW EUDAMED
- Model / Reference
- NHRS, NHPS - F/G, SP, NW EUDAMEDNHPS-3036S EUDAMEDNHPS-3024S EUDAMEDNHPS-6034S EUDAMEDNHPS-4026S EUDAMEDNHPS-2012S EUDAMEDNHPS-4016S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809270469928 EUDAMED08809270469867 EUDAMED08809270469980 EUDAMED08809270469942 EUDAMED08809270469843 EUDAMED08809270469935 EUDAMED
- Basic UDI-DI
- 880927046SPLINTVM EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
NEAL Pre-cut Splint SP by BL Tech — Class I — 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 | 880927046SPLINTVM | Class I | Active |
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Manufacturer
- Manufacturer
- BL Tech
- EUDAMED SRN
- KR-MF-000013035
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED 7133f94e-071d-4fa9-b475-32e90342257d 61 fields · synced Jul 24, 2026
- EUDAMED 75ec5c54-ac7d-44e6-9119-0b0c4fa696e9 61 fields · synced May 16, 2026
- EUDAMED cba049a0-b2d2-4404-845a-49c860e2bb55 61 fields · synced May 16, 2026
- EUDAMED 8b715356-2bac-4a73-aad9-89329f30062f 61 fields · synced May 18, 2026
- EUDAMED 9dbb73e7-034a-49d5-a7e7-4a6d27f90f5f 61 fields · synced May 18, 2026
- EUDAMED bb915c38-4337-4139-b376-ccb6cd334b53 61 fields · synced May 19, 2026