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VivaDiag™ MDPHP Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VDMDP-A101Ref VDMDP-A104Ref VDMDP-A102
Identity
- Trade Name
- VivaDiag™ MDPHP Rapid Test EUDAMED
- Model / Reference
- VDMDP-A101 EUDAMEDVDMDP-A104 EUDAMEDVDMDP-A102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VDMDP-A101FZ EUDAMEDD-VDMDP-A104G7 EUDAMEDD-VDMDP-A102G3 EUDAMED
- Basic UDI-DI
- B-VDMDP-A101FZ EUDAMEDB-VDMDP-A104G7 EUDAMEDB-VDMDP-A102G3 EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
VivaDiag™ MDPHP Rapid Test by VivaChek Biotech (Hangzhou) 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-VDMDP-A101FZ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 4da0aa85-34dc-41bd-b04b-1878f7444804 61 fields · synced Oct 6, 2026
- EUDAMED e6e603cc-ccff-47b8-a015-2c84a8afe548 61 fields · synced May 17, 2026
- EUDAMED 2c0b4ae0-0953-4fa4-ad4f-bdad011e3122 61 fields · synced May 18, 2026