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Total Cholesterol (CHO) Test Kit (CHOD-PAP)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref R：120mL×1(703)Ref R:60mL×2(701)Ref R:40mL×4(793)Ref R:40mL×4 (704)Ref R:40mL×4(716)Ref R:100mL×2(708)Ref R:40mL×4(715)Ref R:20mL×8(710)
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：120mL×1(703) EUDAMEDR:60mL×2(701) EUDAMEDR:40mL×4(793) EUDAMEDR:40mL×4 (704) EUDAMEDR:40mL×4(716) EUDAMEDR:100mL×2(708) EUDAMEDR:40mL×4(715) EUDAMEDR:20mL×8(710) EUDAMEDR:20mL×8 FDA UDIR:100mL×2 FDA UDIR:60mL×2 FDA UDIR:40mL×4 FDA UDIR120mL×1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674860051 EUDAMEDFDA UDI06971674860020 EUDAMEDFDA UDI06971674860174 EUDAMEDFDA UDI06971674860105 EUDAMEDFDA UDI06971674860181 EUDAMEDFDA UDI06971674860198 EUDAMEDFDA UDI06971674860068 EUDAMEDFDA UDI06971674860136 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674860051 EUDAMEDB-06971674860020 EUDAMEDB-06971674860136 EUDAMEDB-06971674860068 EUDAMEDB-06971674860198 EUDAMEDB-06971674860105 EUDAMEDB-06971674860181 EUDAMEDB-06971674860174 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
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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- Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General
- Total Cholesterol (TC) — Maccura Biotechnology Co., Ltd. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674860051 | 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 (17)
- EUDAMED 97afd107-8de5-4924-910d-94cee04c67e4 61 fields · synced Jul 20, 2026
- EUDAMED a0d689cc-7220-4d0b-9c9f-6ad1878ea6c5 61 fields · synced May 18, 2026
- FDA UDI b92c49b4-5284-4f1a-8fa1-4a938e470967 32 fields · synced May 29, 2026
- FDA UDI 6234c70a-fa10-4d50-9d0c-e4de304868f5 32 fields · synced May 29, 2026
- FDA UDI 3b2624b6-ce69-47e5-bae5-605135ad0134 32 fields · synced May 29, 2026
- FDA UDI 64324559-c127-4d19-8baf-4e9b4021c31b 32 fields · synced May 30, 2026
- FDA UDI 29a76ef2-6ec6-41db-94e3-c0cf0a61a634 32 fields · synced May 30, 2026
- FDA UDI 798ad240-57bd-4dcd-b572-4cd1d49d12e9 32 fields · synced May 30, 2026
- FDA UDI ca989648-80f0-4633-8e1f-ce544beb954d 32 fields · synced May 30, 2026
- FDA UDI d7ff41d5-c3b5-4614-9f25-7e89760c592a 32 fields · synced May 30, 2026
- EUDAMED ac1b18ed-f1c0-4365-9173-fec4f140a86a 61 fields · synced Jul 9, 2026
- EUDAMED c39681e3-bcf9-4439-8906-d966ab778c3d 61 fields · synced Jul 13, 2026
- EUDAMED 66c869a8-cf14-4a5b-98ed-77886a683b41 61 fields · synced Jul 15, 2026
- EUDAMED c9a55e40-0d90-41ec-b12d-749a8f2b710f 61 fields · synced Jul 16, 2026
- EUDAMED 9e3ae1d4-196c-4057-a773-a9129991755e 61 fields · synced Jul 17, 2026
- EUDAMED 9ecf2e37-bde9-4cf8-a64b-7cfbe08b45c7 61 fields · synced Jul 19, 2026
- EUDAMED 525a25bb-1346-45c5-bed8-71db6b89574e 61 fields · synced Jul 20, 2026