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ULfast Real Time PCR
EUDAMEDClass A (EU MDR)
Ref SEP5400101Model SEP204、SEP208、SEP104、SEP108、SEP116
Identity
- Trade Name
- ULfast Real Time PCR EUDAMED
- Device Name
- ULfast Real Time PCR EUDAMED
- Model / Reference
- SEP204、SEP208、SEP104、SEP108、SEP116 EUDAMEDSEP5400101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974345075402 EUDAMED
- Basic UDI-DI
- 697434507SEPTT EUDAMED
- Direct Marketing DI
- 06974345075402 EUDAMED
- EMDN Code
- W02060201 POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - INSTRUMENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
ULfast Real Time PCR by Amazing Biotech (Shanghai) 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 | 697434507SEPTT | Class A | Active |
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Manufacturer
- Manufacturer
- Amazing Biotech (Shanghai) Co., LTD
- EUDAMED SRN
- CN-MF-000022383
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 5ffeb15e-39b6-421e-a329-c9c78fc9f3cf 61 fields · synced Jul 23, 2026