Identity
- Trade Name
- IsFlower QC Beads EUDAMED
- Device Name
- IsFlower QC Beads EUDAMED
- Model / Reference
- C.Mb.0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975309200410 EUDAMED
- Basic UDI-DI
- 697530920305JU EUDAMED
- EMDN Code
- W0103080401 SETUP BEADS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia 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
New Device
No
EUDAMED
IsFlower QC Beads by Beijing Challen Biotechnology 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 | 697530920305JU | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Challen Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023656
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e425fc40-2f87-45f9-a7c3-86b8b1239a1b 61 fields · synced Jun 18, 2026