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iFlash-Mycoplasma pn. IgM

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref C88004M-SRef C88004M

by Shenzhen YHLO Biotech Co., Ltd.

Identity

Trade Name
iFlash-Mycoplasma pn. IgM EUDAMEDFDA UDI
Generic Name
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
iFlash-Mycoplasma pn. IgM EUDAMED
Model / Reference
C88004M EUDAMEDFDA UDI
C88004M-S EUDAMED

Identifiers

Primary DI / UDI-DI
06925912719205 EUDAMEDFDA UDI
06925912723769 EUDAMED
Basic UDI-DI
692591270094HL EUDAMED
FDA Product Code
GSA FDA UDI
EMDN Code
W0105010802 MYCOPLASMA ANTIBODY ASSAYS EUDAMED
GMDN Term
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class C EUDAMED
Class I FDA UDI
Regulation Number
866.3375 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

iFlash-Mycoplasma pn. IgM by Shenzhen YHLO Biotech Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen YHLO Biotech Co., Ltd.

Sources (3)

  • FDA UDI 5db470c8-c089-4f83-9999-692f7addd966 32 fields · synced Jul 24, 2026
  • EUDAMED 46f12fb7-b50e-40f6-807d-b45f166fa278 61 fields · synced Jul 23, 2026
  • EUDAMED 67d60c64-ccde-491d-8a1d-aa6209389334 61 fields · synced Jul 24, 2026