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OrthoThermic Gloves
EUDAMEDClass I (EU MDR)
Ref NC54100-LGModel 4250Ref NC54100-MDRef NC54100-XXL
Identity
- Trade Name
- OrthoThermic Gloves EUDAMED
- Device Name
- OrthoThermic Gloves EUDAMED
- Model / Reference
- 4250 EUDAMEDNC54100-LG EUDAMEDNC54100-MD EUDAMEDNC54100-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627006811 EUDAMED00768627006798 EUDAMED00768627006835 EUDAMED
- Basic UDI-DI
- 0768627COMPR-4250-9S EUDAMED
- Direct Marketing DI
- 00768627006811 EUDAMED00768627006798 EUDAMED00768627006835 EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Category: Compression/pressure sock/stocking, single-use
OrthoThermic Gloves by North Coast Medical, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0768627COMPR-4250-9S | Class I | Active |
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Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (3)
- EUDAMED e5ace873-1dcc-46f0-992c-2d2c100bcd55 61 fields · synced Jul 22, 2026
- EUDAMED dbf05011-9ed4-426e-87b1-95d1e925b805 61 fields · synced May 18, 2026
- EUDAMED 10e936c0-2a9c-41e2-8a50-06f900af6968 61 fields · synced May 19, 2026