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SureScreen Covid/Flu Test Reader
EUDAMEDClass A (EU MDR)
Ref SCFR
by TestCard Ltd
Identity
- Trade Name
- SureScreen Covid/Flu Test Reader EUDAMED
- Device Name
- SureScreen Covid/Flu Test Reader EUDAMED
- Model / Reference
- SCFR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50606975731007 EUDAMED
- Basic UDI-DI
- 506069757SCFRFE EUDAMED
- Direct Marketing DI
- 50606975731007 EUDAMED
- EMDN Code
- W020101020101 URINE STRIP READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
SureScreen Covid/Flu Test Reader by TestCard Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 506069757SCFRFE | Class A | Active |
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Manufacturer
- Manufacturer
- TestCard Ltd
- EUDAMED SRN
- GB-MF-000013002
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED e079382f-becb-44e6-a214-d17fc2a20a61 61 fields · synced Sep 17, 2026