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Finder

FDA UDI

Class II (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
FINDER FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Device Name
FINDER Instrument FDA UDI
Model / Reference
3409 FDA UDI
Description
FINDER Instrument FDA UDI

Identifiers

Primary DI / UDI-DI
00819704020333 FDA UDI
510(k) Number
K201049 FDA UDI
FDA Product Code
JBF FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7360 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyser IVD, point-of-care

Finder by Baebies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, point-of-care.

Cleared under the same submission

K201049 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI 5de814a7-374c-4e5c-92cd-6007587afc26 35 fields · synced May 30, 2026