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Fentanyl Qualitative Calibrator Set

EUDAMEDFDA UDI

Class B (EU MDR)

Ref 09330097190

by Lin-Zhi International, Inc.

Identity

Trade Name
Fentanyl Qualitative Calibrator Set EUDAMEDFDA UDI
Generic Name
Fentanyl IVD, calibrator FDA UDI
Device Name
Fentanyl Calibrators and Controls EUDAMED
FEN Cutoff Calibrator 5 ng/mL (1 x 5 mL). FDA UDI
Model / Reference
09330097190 EUDAMEDFDA UDI
Description
FEN Cutoff Calibrator 5 ng/mL (1 x 5 mL). FDA UDI

Identifiers

Catalog Number
09330097190 FDA UDI
Primary DI / UDI-DI
00850624008278 EUDAMEDFDA UDI
Basic UDI-DI
0850624008CCFEN2024V EUDAMED
Direct Marketing DI
00850624008278 EUDAMED
FDA Product Code
DLJ FDA UDI
EMDN Code
W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
GMDN Term
Fentanyl IVD, calibrator FDA UDI

Classification

Device Class
Class B EUDAMED
Class II FDA UDI
Regulation Number
862.3200 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

No

EUDAMED

Reagent

No

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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Fentanyl Qualitative Calibrator Set by Lin-Zhi International, Inc. — Class B — 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

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

Manufacturer

Manufacturer
Lin-Zhi International, Inc.
EUDAMED SRN
US-MF-000003373
Authorised Representative
CEpartner4U NL-AR-000000111

Sources (2)

  • EUDAMED 2c9947e5-cf3f-4171-b055-52219592c9e7 61 fields · synced Jun 18, 2026
  • FDA UDI 6fc4e20c-e771-451b-bc83-f12c965273cd 35 fields · synced May 30, 2026