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Elina med Kalt-/Warm-Kompresse
EUDAMEDClass I (EU MDR)
Ref 12x29cm REF:41433 / 15x16 cm REF:62269Model Assortment 2
Identity
- Trade Name
- Elina med Kalt-/Warm-Kompresse EUDAMED
- Device Name
- Elina med Kalt-/Warm-Kompresse EUDAMED
- Model / Reference
- Assortment 2 EUDAMED12x29cm REF:41433 / 15x16 cm REF:62269 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589090660 EUDAMED
- Basic UDI-DI
- B-06973589090660 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Elina med Kalt-/Warm-Kompresse by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973589090660 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ba73185c-b3fa-4f57-8780-4a1e60a4e71b 61 fields · synced Jun 18, 2026