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Superfirt
EUDAMEDClass I (EU MDR)
Ref SOFT GEL PACKModel ICE PACK,HOT PACK,HOT COLD PACK,SOFT GEL PACK
Identity
- Trade Name
- Superfirt EUDAMED
- Device Name
- HOT COLD PACK(Hot/cold gel ice bag) EUDAMED
- Model / Reference
- ICE PACK,HOT PACK,HOT COLD PACK,SOFT GEL PACK EUDAMEDSOFT GEL PACK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976400130163 EUDAMED
- Basic UDI-DI
- 697640013HCP01CA EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Superfirt by Nanjing Superfit I & E Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697640013HCP01CA | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Superfit I & E Co., Ltd.
- EUDAMED SRN
- CN-MF-000040037
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d6ec7a42-6cbd-4089-9799-b8e6a7bb1692 61 fields · synced Jun 18, 2026