Identity
- Trade Name
- Sejoy EUDAMED
- Device Name
- BS-606 Blood Glucose Test Strips EUDAMEDBG-709g Blood Glucose Monitoring System EUDAMED
- Model / Reference
- BS-606 EUDAMEDBG-709g EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-693966398022S EUDAMEDD-69396639H6 EUDAMED
- Basic UDI-DI
- B-693966398022S EUDAMEDB-69396639H6 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMEDW0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
Sejoy by Sejoy Biomedical Co., Ltd. — Class IVD Annex II List B — 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-693966398022S | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e37be00b-5e38-497a-b916-75d05f65ddf2 61 fields · synced Jul 27, 2026
- EUDAMED bb953362-566d-413e-8abb-ada7e4de8ecb 61 fields · synced May 18, 2026