Mercodia Ultrasensitive Insulin ELISA
FDA UDIEUDAMEDClass I (US FDA UDI)
by Mercodia AB
Identity
- Trade Name
- Mercodia Ultrasensitive Insulin ELISA EUDAMEDFDA UDI
- Generic Name
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Ultrasensitive Insulin ELISA EUDAMEDMercodia Ultrasensitive Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma. FDA UDI
- Model / Reference
- 10-1132-01 EUDAMEDFDA UDI
- Description
- Mercodia Ultrasensitive Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- 10-1132-01 FDA UDI
- Primary DI / UDI-DI
- 07350108630061 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350108630061 EUDAMED
- FDA Product Code
- CFP FDA UDI
- EMDN Code
- W0102060103 INSULIN EUDAMED
- GMDN Term
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1405 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Insulin IVD, kit, enzyme immunoassay (EIA)
Mercodia Ultrasensitive Insulin ELISA by Mercodia AB — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mercodia AB
Sources (2)
- FDA UDI 6731b5a3-d9e0-41fa-95db-707750d7f83a 36 fields · synced Jul 13, 2026
- EUDAMED 603435b5-5133-4065-a4da-955be3ac3d17 61 fields · synced Jul 13, 2026