Identity
- Device Name
- PCR-CE DMD gene Kit EUDAMED
- Model / Reference
- 04110006 EUDAMED04110005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975358885217 EUDAMED06975358885200 EUDAMED
- Basic UDI-DI
- B-06975358885217 EUDAMEDB-06975358885200 EUDAMED
- EMDN Code
- W0106010102 DUCHENNE MUSCULAR DYSTROPHY 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 DMD gene 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-06975358885217 | 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 (2)
- EUDAMED 21e5ceb6-1a86-49e8-9679-5739e90aafd9 61 fields · synced Oct 7, 2026
- EUDAMED 7662e224-410b-4680-98c5-4c289d5494d9 61 fields · synced May 18, 2026