Identity
- Trade Name
- small dense LDL Seiken EUDAMEDFDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- small dense LDL Seiken EUDAMED
- Model / Reference
- 08834075190 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 08834075190 FDA UDI
- Primary DI / UDI-DI
- 04987503562890 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987503sdLDLNY EUDAMED
- 510(k) Number
- K161679 FDA UDI
- FDA Product Code
- PYP FDA UDI
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 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
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
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
No
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 Seiken 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 | 4987503sdLDLNY | 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 aee3b4a0-3ac7-49a5-8c82-9e6e6cf88a42 61 fields · synced Jun 18, 2026
- FDA UDI b2fe712c-c95c-420f-8d95-abdc5f74e0e7 34 fields · synced May 30, 2026