Identity
- Trade Name
- iFlash-EB NA IgA EUDAMED
- Device Name
- iFlash-EB NA IgA EUDAMED
- Model / Reference
- C88012A-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912723745 EUDAMED
- Basic UDI-DI
- 692591270086HM EUDAMED
- EMDN Code
- W010504040199 EBV ANTIBODIES - OTHER 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-EB NA IgA 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 | 692591270086HM | 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 (1)
- EUDAMED 9393d691-7efe-41ea-8a0d-c12fc7c9eb80 61 fields · synced Jul 9, 2026