Identity
- Trade Name
- Pluslife Strep A Card EUDAMED
- Device Name
- Strep A Nucleic Acid Test Card EUDAMED
- Model / Reference
- RM1010702-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975327120127 EUDAMED
- Basic UDI-DI
- B-06975327120127 EUDAMED
- EMDN Code
- W0105011103 STREP. A DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General 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
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Pluslife Strep A Card by Guangzhou Pluslife Biotech Co., Ltd — Class IVD General — 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-06975327120127 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Pluslife Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000025784
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c9b49254-b50e-4a7b-8bf1-9cf515e9ecde 61 fields · synced Jul 27, 2026