Identity
- Trade Name
- OrthoThermic Gloves EUDAMED
- Device Name
- OrthoThermic Gloves EUDAMED
- Model / Reference
- 4250 EUDAMEDNC54100-XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627006552 EUDAMED
- Basic UDI-DI
- 0768627COMPR-4250-9S EUDAMED
- Direct Marketing DI
- 00768627006552 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
Similar devices
Also classified as Compression/pressure sock/stocking, single-use.
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain soft — Bauerfeind GmbH & Co. · Class II
- VenoTrain soft S — Bauerfeind GmbH & Co. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain micro — Bauerfeind GmbH & Co. · Class II
- VenoTrain soft, AG, Top band silicone micro dots, Ccl2, open toe, L Plus short, Cream — Bauerfeind AG · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED cf9cbfad-26af-4ce9-a5df-9b6e87353db6 61 fields · synced Jun 17, 2026