Identity
- Trade Name
- iFlash-HSV-1 IgM EUDAMED
- Device Name
- iFlash-HSV-1 IgM EUDAMED
- Model / Reference
- C88041M EUDAMEDC88041M-L EUDAMEDC88041M-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912719007 EUDAMED06925912715597 EUDAMED06925912723554 EUDAMED
- Basic UDI-DI
- 692591270062H7 EUDAMED
- EMDN Code
- W0105040307 HSV 1 IGM EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
iFlash-HSV-1 IgM by Shenzhen Yhlo Biotech Co., Ltd. — Class C — 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 | 692591270062H7 | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED af960400-580e-46ac-9b79-4c40e847800c 61 fields · synced Jul 31, 2026
- EUDAMED ca3bb1df-ac0e-48ea-82c9-34997bc7168e 61 fields · synced Jul 8, 2026
- EUDAMED 754294ca-60b3-467f-8949-d33cc063e8a6 61 fields · synced Jul 31, 2026