← Back to catalogue

Uniqo 160

FDA UDI

Class I (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
UNIQO 160 FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Model / Reference
YG 2900-0101-1 FDA UDI

Identifiers

Primary DI / UDI-DI
04049016159018 FDA UDI
FDA Product Code
JQW FDA UDI
IBK FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2750 FDA UDI
864.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratory

Uniqo 160 by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI 1f559e6a-36be-4e87-9532-0b7cd25dc0ef 32 fields · synced May 30, 2026