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Superfirt
EUDAMEDClass I (EU MDR)
Ref TPEModel TPE,TPE+ABS,POLYESTER+ABS, 2.5*36cm, 2.5*40cm,2.5*45cm
Identity
- Trade Name
- Superfirt EUDAMED
- Device Name
- Tourniquet EUDAMED
- Model / Reference
- TPE,TPE+ABS,POLYESTER+ABS, 2.5*36cm, 2.5*40cm,2.5*45cm EUDAMEDTPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976400130330 EUDAMED
- Basic UDI-DI
- 697640013TOT01KN EUDAMED
- EMDN Code
- V9003 TOURNIQUETS 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: Limb tourniquet, manual, reusable
Superfirt by Nanjing Superfit I & E Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Limb tourniquet, manual, 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 | 697640013TOT01KN | 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 123f6ee8-94df-402b-9263-008c5debe602 61 fields · synced Jun 20, 2026