Identity
- Trade Name
- Magic Gel EUDAMED
- Device Name
- Hot cold pack EUDAMED
- Model / Reference
- Back01,M02,Cos01,Al01,Ex03 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973713951812 EUDAMED
- Basic UDI-DI
- 697371395hotcoldpack77 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
Magic Gel by Shanghai Bing Fan Industrial Co., Ltd. — 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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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 | 697371395hotcoldpack77 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Bing Fan Industrial Co., Ltd.
- EUDAMED SRN
- CN-MF-000009833
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 2a0fb0fe-2663-4595-b1ca-04439541f904 61 fields · synced Jul 26, 2026
- EUDAMED 2a0fb0fe-2663-4595-b1ca-04439541f904-1 61 fields · synced Jun 9, 2026