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Superfirt
EUDAMEDClass I (EU MDR)
Ref 1000CCModel 500CC/750CC/1000CC/1500CC/2000CC/3000CC
Identity
- Trade Name
- Superfirt EUDAMED
- Device Name
- Enema Bag EUDAMED
- Model / Reference
- 500CC/750CC/1000CC/1500CC/2000CC/3000CC EUDAMED1000CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976400130491 EUDAMED
- Basic UDI-DI
- 697640013ENB01BG EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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 | 697640013ENB01BG | 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 330d90dd-e7d2-4961-a5cd-04776738cea3 61 fields · synced Jun 17, 2026