Identity
- Trade Name
- Fentanyl Control Set EUDAMEDFDA UDI
- Generic Name
- Fentanyl IVD, control FDA UDI
- Device Name
- Fentanyl Calibrators and Controls EUDAMEDFEN Negative Control 3.75 ng/mL (2 x 15 mL), FEN Positive Control 6.25 ng/mL (2 x 15 mL). FDA UDI
- Model / Reference
- 10426667190 EUDAMEDFDA UDI
- Description
- FEN Negative Control 3.75 ng/mL (2 x 15 mL), FEN Positive Control 6.25 ng/mL (2 x 15 mL). FDA UDI
Identifiers
- Catalog Number
- 10426667190 FDA UDI
- Primary DI / UDI-DI
- 00850624008636 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850624008CCFEN2024V EUDAMED
- Direct Marketing DI
- 00850624008636 EUDAMED
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- Fentanyl IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 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 Control 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850624008CCFEN2024V | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
- EUDAMED SRN
- US-MF-000003373
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 3092793e-7f1b-4e74-b6bc-2ee73a92f216 61 fields · synced Jun 19, 2026
- FDA UDI 8789bf5f-110e-445c-9025-eb2cfe532583 35 fields · synced May 27, 2026