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Hemoglobin Analysis Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref 3020100501Model BHS-101（50pcs）Ref 3020100301Model BHS-101（25pcs）
Identity
- Device Name
- Hemoglobin Analysis Test Strip EUDAMED
- Model / Reference
- BHS-101（50pcs） EUDAMED3020100501 EUDAMEDBHS-101（25pcs） EUDAMED3020100301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697177120106189 EUDAMEDD-69717712010478F EUDAMED
- Basic UDI-DI
- B-697177120106189 EUDAMEDB-69717712010478F EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Hemoglobin Analysis Test Strip by Hangzhou Lysun Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-697177120106189 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 209bcfd7-4bab-40cd-a451-f86075a279be 61 fields · synced Oct 6, 2026
- EUDAMED 9562bd82-7826-4158-af33-51c01742db27 61 fields · synced May 16, 2026