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Superfirt
EUDAMEDClass I (EU MDR)
Ref SBF-096Model SBF-085,SBF-086,SBF-087,SBF-088,SBF-089, SBF-090,SBF-091,SBF-092,SBF-093,SBF-094,SBF-095, SBF-096
Identity
- Trade Name
- Superfirt EUDAMED
- Device Name
- Electric Hot Water Bag/Electric Hot Water Bottle EUDAMED
- Model / Reference
- SBF-085,SBF-086,SBF-087,SBF-088,SBF-089, SBF-090,SBF-091,SBF-092,SBF-093,SBF-094,SBF-095, SBF-096 EUDAMEDSBF-096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976400130699 EUDAMED
- Basic UDI-DI
- 697640013EHWB01DS 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
Category: Hot/cold therapy pack, reusable
Superfirt by Nanjing Superfit I & E Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- 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 | 697640013EHWB01DS | 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 c098997a-a2b5-4edf-9c87-c1c68a979759 61 fields · synced Jun 18, 2026