Identity
- Trade Name
- small dense LDL-Calibrator EUDAMEDsmall dense LDL Calibrator FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- small dense LDL-Calibrator EUDAMED
- Model / Reference
- 08834091190 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 08834091190 FDA UDI
- Primary DI / UDI-DI
- 04987503563071 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987503sdLDLcalMU EUDAMED
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
small dense LDL-Calibrator by Denka Co., Ltd. — 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 | 4987503sdLDLcalMU | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Denka Co., Ltd.
- EUDAMED SRN
- JP-MF-000015952
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 702ec8a2-266c-44b3-8316-935a418ee40b 61 fields · synced Jun 19, 2026
- FDA UDI e3672016-2b5e-4a2a-aeef-5c62c99dc2d0 34 fields · synced May 30, 2026