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Essential COMFORTABLE
EUDAMEDClass I (EU MDR)
Ref 321913Model Essential COMFORTABLE
by Sigvaris Ag
Identity
- Trade Name
- Essential COMFORTABLE EUDAMED
- Model / Reference
- Essential COMFORTABLE EUDAMED321913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613378211256 EUDAMED
- Basic UDI-DI
- 7611711ECFBX EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Essential COMFORTABLE by Sigvaris Ag — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Compression/pressure sock/stocking, single-use.
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- MEDI — MEDI MANUFACTURING, INC. · Class II
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- 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 | 7611711ECFBX | Class I | Active |
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Manufacturer
- Manufacturer
- Sigvaris Ag
- EUDAMED SRN
- CH-MF-000015565
- Authorised Representative
- Sigvaris GmbH DE-AR-000010016
Sources (1)
- EUDAMED c174e964-0afd-4ab0-962e-2feeb54fec0c 61 fields · synced Jul 29, 2026