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Dr. Max Digital Pregnancy Rapid Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 0811S7X001Model DC811
Identity
- Trade Name
- Dr. Max Digital Pregnancy Rapid Test EUDAMED
- Device Name
- Digital Pregnancy Rapid Test EUDAMED
- Model / Reference
- DC811 EUDAMED0811S7X001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8595566428563GB EUDAMED
- Basic UDI-DI
- B-8595566428563GB EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Dr. Max Digital Pregnancy Rapid Test by Guangzhou Decheng Biotechnology Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-8595566428563GB | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Guangzhou Decheng Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000013536
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 8b2e8e03-bc7c-40bb-b7f9-093735deb205 61 fields · synced Jun 18, 2026