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Fmr1 Cgg Pcr
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/KitRef 50 Tests/Kit
Identity
- Device Name
- FMR1 CGG PCR EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED50 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-10106010104029X2 EUDAMEDD-00106010104013V8 EUDAMED
- Basic UDI-DI
- B-10106010104029X2 EUDAMEDB-00106010104013V8 EUDAMED
- EMDN Code
- W0106010104 FRAGILE X SYNDROME EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Fmr1 Cgg Pcr by Beijing Healthgene Laboratory 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-10106010104029X2 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Healthgene Laboratory Co., Ltd
- EUDAMED SRN
- CN-MF-000032465
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED cb43036c-b49e-4e9d-a403-0277f25bd595 61 fields · synced Jul 10, 2026
- EUDAMED 2c27d035-0cf5-4dcb-aae6-17999ff85f09 61 fields · synced May 17, 2026