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Essential THERMOREGULATING
EUDAMEDClass I (EU MDR)
Ref 64108Model Essential THERMOREGULATING
by Sigvaris Ag
Identity
- Trade Name
- Essential THERMOREGULATING EUDAMED
- Model / Reference
- Essential THERMOREGULATING EUDAMED64108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611711641081 EUDAMED
- Basic UDI-DI
- 7611711ETHDN 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 THERMOREGULATING 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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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 | 7611711ETHDN | 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 ab82d8d2-8902-45bd-96ae-7f45fec8eb69 61 fields · synced Jul 8, 2026