← Back to catalogue
Folate test (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref HGCL97Model Please see the IFU
Identity
- Trade Name
- Folate test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Folate test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL97 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700408980 EUDAMED
- Basic UDI-DI
- 697029753466M4 EUDAMED
- EMDN Code
- W0102070103 FOLATE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Folate test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class B — 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 | 697029753466M4 | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 85509dc8-faf2-4c21-9809-c6f94a424b99 61 fields · synced Jun 18, 2026