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SISSEL® Hot-Cold Pearl Eye Mask
EUDAMEDClass I (EU MDR)
Ref 150.042Model SISSEL® THERM
by SISSEL GmbH
Identity
- Trade Name
- SISSEL® Hot-Cold Pearl Eye Mask EUDAMED
- Device Name
- SISSEL® THERM tri-sectional EUDAMED
- Model / Reference
- SISSEL® THERM EUDAMED150.042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250694711928 EUDAMED
- Basic UDI-DI
- 42506947M90019N EUDAMED
- Direct Marketing DI
- 04250694711928 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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: Hot/cold therapy pack, reusable
SISSEL® Hot-Cold Pearl Eye Mask by SISSEL GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · 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 | 42506947M90019N | Class I | Active |
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Manufacturer
- Manufacturer
- SISSEL GmbH
- EUDAMED SRN
- DE-MF-000007624
Sources (1)
- EUDAMED d9cd4777-bfc6-4479-bbc8-1a3b5eab5226 61 fields · synced Jul 27, 2026