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Neal Splint N
EUDAMEDClass I (EU MDR)
Ref NHRS-5450NModel NHRS, NHPS - F/G, SP, NWRef NHRS-2450NRef NHRS-7450NRef NHRS-3450NRef NHRS-8450N
by BL Tech
Identity
- Trade Name
- NEAL SPLINT N EUDAMED
- Device Name
- NHRS, NHPS - F/G, SP, NW EUDAMED
- Model / Reference
- NHRS, NHPS - F/G, SP, NW EUDAMEDNHRS-5450N EUDAMEDNHRS-2450N EUDAMEDNHRS-7450N EUDAMEDNHRS-3450N EUDAMEDNHRS-8450N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809270467382 EUDAMED08809270467351 EUDAMED08809270466729 EUDAMED08809270467368 EUDAMED08809270466736 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 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 a0bb951a-18f8-4280-b58b-b8b7959a4fb9 61 fields · synced Aug 4, 2026
- EUDAMED bed89d16-220c-43ad-b45b-34eaafa4213d 61 fields · synced May 17, 2026
- EUDAMED bd3778cb-149f-4226-9977-04fbefd665e2 61 fields · synced May 17, 2026
- EUDAMED 5c1196b6-dde5-4e9f-af20-2de723c6bba4 61 fields · synced May 18, 2026
- EUDAMED f6d20eb1-cd5a-40b2-9e8d-be67e1654dac 61 fields · synced May 18, 2026