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PCR-CE FMR1 Kit
EUDAMEDClass IVD General (EU MDR)
Ref 04110001Model 48 Tests/Kit
Identity
- Device Name
- PCR-CE FMR1 Kit EUDAMED
- Model / Reference
- 48 Tests/Kit EUDAMED04110001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975358885002 EUDAMED
- Basic UDI-DI
- B-06975358885002 EUDAMED
- EMDN Code
- W0106010104 FRAGILE X SYNDROME EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
PCR-CE FMR1 Kit by Xiamen Biofast Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975358885002 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biofast Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027220
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7eaab5b4-59e7-4902-abec-f682f01fa0c2 61 fields · synced Jun 19, 2026