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Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref CML-101,MLS-101
Identity
- Trade Name
- Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip) EUDAMED
- Device Name
- Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip) EUDAMED
- Model / Reference
- CML-101,MLS-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804813697 EUDAMED
- Basic UDI-DI
- B-06952804813697 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip) by Assure Tech. (hangzhou) Co., Ltd. — Class IVD devices for self-testing — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06952804813697 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4b51c62b-2a14-40a8-9594-aeb7d2f4f046 61 fields · synced Oct 6, 2026
- EUDAMED 4b51c62b-2a14-40a8-9594-aeb7d2f4f046-1 61 fields · synced Jun 9, 2026