← Back to catalogue
JS100 Blood Glucose Monitoring System (Standard Plus) (CE)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref JS100
Identity
- Trade Name
- JS100 Blood Glucose Monitoring System (Standard Plus) (CE) EUDAMED
- Device Name
- JS100 Blood Glucose Monitoring System (Standard Plus) (CE) EUDAMED
- Model / Reference
- JS100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719869704115 EUDAMED
- Basic UDI-DI
- B-04719869704115 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
JS100 Blood Glucose Monitoring System (Standard Plus) (CE) by Tyson Bioresearch, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED
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-04719869704115 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tyson Bioresearch, Inc.
- EUDAMED SRN
- TW-MF-000027508
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 9a8b7fb9-30f5-448b-8e65-79e943dfb252 61 fields · synced Oct 6, 2026