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Spengler TB100
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 745012Model Spengler TB100
Identity
- Trade Name
- Spengler TB100 EUDAMED
- Device Name
- Spengler TB100 Control Solution EUDAMED
- Model / Reference
- Spengler TB100 EUDAMED745012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-T05D5710004SNKZ EUDAMED
- Basic UDI-DI
- B-T05D5710004SNKZ EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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-T05D5710004SNKZ | 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 (1)
- EUDAMED e3d15178-a090-420f-b586-d5087f8d99f1 61 fields · synced Jun 19, 2026