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Spengler TB100
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 745000Model Spengler TB100Ref 745010
Identity
- Trade Name
- Spengler TB100 EUDAMED
- Device Name
- Spengler TB100 Blood Glucose Monitoring System EUDAMEDSpengler TB100 Blood Glucose Test Strips EUDAMED
- Model / Reference
- Spengler TB100 EUDAMED745000 EUDAMED745010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-T05D5710001KNJS EUDAMEDD-T05D5710003ANJ6 EUDAMED
- Basic UDI-DI
- B-T05D5710001KNJS EUDAMEDB-T05D5710003ANJ6 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101 GLUCOSE TEST STRIPS 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
EUDAMEDEUDAMED
Spengler TB100 by Tyson Bioresearch, Inc. — 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-T05D5710001KNJS | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Tyson Bioresearch, Inc.
- EUDAMED SRN
- TW-MF-000027508
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 13073afb-dbd0-411b-923b-e507f5ab41d5 61 fields · synced Jul 26, 2026
- EUDAMED 66dd8a56-db62-4b57-9541-d7fcfde5b536 61 fields · synced May 18, 2026