Identity
- Trade Name
- small dense LDL-Control Set EUDAMEDsmall dense LDL Control Set FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, control FDA UDI
- Device Name
- small dense LDL-Control Set EUDAMED
- Model / Reference
- 08834105190 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 08834105190 FDA UDI
- Primary DI / UDI-DI
- 04987503563088 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987503sdLDLconPA EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050202 LIPID CONTROLS EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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-Control Set 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 | 4987503sdLDLconPA | 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 6bf2bbb5-37ee-4969-bcfa-5be91b6460cf 61 fields · synced Jul 11, 2026
- FDA UDI eeadd4f8-45cc-40dc-bf2a-b0cd48ccc00c 34 fields · synced May 30, 2026