Total Cholesterol (CHO) Test Kit (CHOD-PAP)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- Total Cholesterol (CHO) Test Kit (CHOD-PAP) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Total cholesterol lipid IVD, reagent FDA UDI
- Device Name
- Total Cholesterol (CHO) Test Kit (CHOD-PAP) EUDAMED
- Model / Reference
- R:20mL×2(702) EUDAMEDR:20mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674860044 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674860044 EUDAMED
- FDA Product Code
- CGO FDA UDI
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
- GMDN Term
- Total cholesterol lipid IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Market of Registration
- Germany 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
No
Microbial Substances
No
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
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Total cholesterol lipid IVD, reagent
Total Cholesterol (CHO) Test Kit (CHOD-PAP) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Total cholesterol lipid IVD, reagent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674860044 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 9f911295-de5b-4318-bd6f-47a333c00910 61 fields · synced Jun 18, 2026
- FDA UDI 1cd8d973-e459-4305-b879-6d57cbd0651f 32 fields · synced May 30, 2026