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Superfirt
EUDAMEDClass A (EU MDR)
Ref 1000mlModel 30ml/60ml/250ml/500ml/1000ml/2500ml/5000ml
Identity
- Trade Name
- Superfirt EUDAMED
- Device Name
- Reagent Bottle EUDAMED
- Model / Reference
- 30ml/60ml/250ml/500ml/1000ml/2500ml/5000ml EUDAMED1000ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976400131863 EUDAMED
- Basic UDI-DI
- 697640013REB01DY EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Superfirt by Nanjing Superfit I & E Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697640013REB01DY | Class A | 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 98547d5d-f267-4f87-8075-58aeb15d05b9 61 fields · synced Jun 18, 2026