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NEAL Pre-cut Splint F

EUDAMED

Class I (EU MDR)

Ref NHPS-4018FModel NHRS, NHPS - F/G, SP, NWRef NHPS-4034FRef NHPS-3040FRef NHPS-2012FRef NHPS-6050F

by BL Tech

Identity

Trade Name
NEAL Pre-cut Splint F EUDAMED
Device Name
NHRS, NHPS - F/G, SP, NW EUDAMED
Model / Reference
NHRS, NHPS - F/G, SP, NW EUDAMED
NHPS-4018F EUDAMED
NHPS-4034F EUDAMED
NHPS-3040F EUDAMED
NHPS-2012F EUDAMED
NHPS-6050F EUDAMED

Identifiers

Primary DI / UDI-DI
08809270467528 EUDAMED
08809270467535 EUDAMED
08809270467511 EUDAMED
08809270467498 EUDAMED
08809270467573 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 F 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

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Manufacturer

Manufacturer
BL Tech
EUDAMED SRN
KR-MF-000013035
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (5)

  • EUDAMED 1a97a77a-3cbd-4b9b-9dfd-e530d880dd60 61 fields · synced Jul 28, 2026
  • EUDAMED 3995788c-6d6f-429b-9266-4f255d224029 61 fields · synced May 17, 2026
  • EUDAMED 54c76e4e-1eb7-40df-84cc-2352c3783e87 61 fields · synced May 18, 2026
  • EUDAMED d0a539a6-41f0-4857-a343-29e1d15c27fc 61 fields · synced May 18, 2026
  • EUDAMED 7c728a54-f47d-4e89-a165-83c882d2ceb8 61 fields · synced May 18, 2026