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iFlash-17α-OH-P

EUDAMED

Class B (EU MDR)

Ref C86061-S

by Shenzhen Yhlo Biotech Co., Ltd.

Identity

Trade Name
iFlash-17α-OH-P EUDAMED
Device Name
iFlash-17α-OH-P EUDAMED
Model / Reference
C86061-S EUDAMED

Identifiers

Primary DI / UDI-DI
06925912721130 EUDAMED
Basic UDI-DI
692591270154HD EUDAMED
EMDN Code
W0102050107 17 OH PROGESTERONE 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

iFlash-17α-OH-P by Shenzhen Yhlo 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

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Manufacturer

EUDAMED SRN
CN-MF-000001137
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED a11165c4-222b-4317-91da-f73e6af8b47a 61 fields · synced Jul 11, 2026