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co-innovation

FDA UDI

Class II (US FDA UDI)

by Co-Innovation Biotech Co., Ltd

Identity

Trade Name
co-innovation FDA UDI
Generic Name
Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
14P DRUG TEST CUP FDA UDI

Identifiers

Primary DI / UDI-DI
06970429841420 FDA UDI
510(k) Number
K153050 FDA UDI
FDA Product Code
DMJ FDA UDI
LDJ FDA UDI
LCM FDA UDI
DJR FDA UDI
DNK FDA UDI
DJC FDA UDI
DIO FDA UDI
JXM FDA UDI
DJG FDA UDI
DIS FDA UDI
DKZ FDA UDI
GMDN Term
Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3040 FDA UDI
862.3870 FDA UDI
862.3620 FDA UDI
862.3640 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3650 FDA UDI
862.3150 FDA UDI
862.3100 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

co-innovation by Co-Innovation Biotech Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153050 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Co-Innovation Biotech Co., Ltd

Sources (1)

  • FDA UDI 502e2f8c-9da2-4c9a-bcc7-e17d23f85658 34 fields · synced May 31, 2026