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iFlash-Chlamydia pn. IgG
EUDAMEDClass C (EU MDR)
Ref C88013GRef C88013G-SRef C88013G-L
Identity
- Trade Name
- iFlash-Chlamydia pn. IgG EUDAMED
- Device Name
- iFlash-Chlamydia pn. IgG EUDAMED
- Model / Reference
- C88013G EUDAMEDC88013G-S EUDAMEDC88013G-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912719212 EUDAMED06925912723776 EUDAMED06925912715771 EUDAMED
- Basic UDI-DI
- 692591270099HW EUDAMED
- EMDN Code
- W0105010115 CHLAMYDIA PNEUMONIAE ANTIBODY IGG 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
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
iFlash-Chlamydia pn. IgG 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 | 692591270099HW | 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 e854013a-13f0-4f54-b3b3-ec65d26cd6b6 61 fields · synced Aug 2, 2026
- EUDAMED aecdf0bc-ce65-4f1a-b0be-805480038a4c 61 fields · synced Jul 19, 2026
- EUDAMED 707dbf44-e0a6-4fa6-89d2-6154a9f236f3 61 fields · synced Aug 2, 2026