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NEAL Pre-cut Splint N
EUDAMEDClass I (EU MDR)
Ref NHPS-3040NModel NHRS, NHPS - F/G, SP, NWRef NHPS-6034NRef NHPS-3014NRef NHPS-5050NRef NHPS-6050N
by BL Tech
Identity
- Trade Name
- NEAL Pre-cut Splint N EUDAMED
- Device Name
- NHRS, NHPS - F/G, SP, NW EUDAMED
- Model / Reference
- NHRS, NHPS - F/G, SP, NW EUDAMEDNHPS-3040N EUDAMEDNHPS-6034N EUDAMEDNHPS-3014N EUDAMEDNHPS-5050N EUDAMEDNHPS-6050N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809270467603 EUDAMED08809270467658 EUDAMED08809270467597 EUDAMED08809270467641 EUDAMED08809270467665 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 N 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 (5)
- EUDAMED 7abe1043-7910-40b5-a01c-93b28e69936f 61 fields · synced Aug 3, 2026
- EUDAMED c1a8fb6c-77bc-4080-a073-e0543aa6826b 61 fields · synced May 16, 2026
- EUDAMED 39781b13-e2a8-4c60-83e3-1e6c01481d66 61 fields · synced May 16, 2026
- EUDAMED ab66517e-2e46-4c88-9845-f187deadeac5 61 fields · synced May 18, 2026
- EUDAMED 330e3659-e7a9-4e5f-9945-3fdf4cfe19fd 61 fields · synced May 19, 2026