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Sample Diluent

EUDAMEDFDA UDI

Class A (EU MDR)

Ref C89919Model I

by Shenzhen Yhlo Biotech Co., Ltd.

Identity

Trade Name
Sample Diluent FDA UDI
Generic Name
Buffered sample diluent IVD FDA UDI
Device Name
Sample Diluent EUDAMED
Sample Diluent I, 45 mL×2 bottles FDA UDI
Model / Reference
I EUDAMED
C89919 EUDAMEDFDA UDI
Description
Sample Diluent I, 45 mL×2 bottles FDA UDI

Identifiers

Primary DI / UDI-DI
06925912716693 EUDAMEDFDA UDI
Basic UDI-DI
692591270176HP EUDAMED
FDA Product Code
PPM FDA UDI
EMDN Code
W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
GMDN Term
Buffered sample diluent IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
864.4010 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

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

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

Sample Diluent by Shenzhen Yhlo Biotech Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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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 (2)

  • EUDAMED 11f76bf7-9a44-49d1-8ba2-203c97e52ef7 61 fields · synced Jul 30, 2026
  • FDA UDI a4bdffae-5817-44e6-9dd0-8ab376eff569 33 fields · synced May 30, 2026