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Boiron
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref B606101Ref A6061253
Identity
- Trade Name
- BOIRON EUDAMED
- Device Name
- Rapid COVID-19 Antigen Test (Colloidal Gold) EUDAMEDBOIRON TEST&CARE COVID-19 AUTOTEST NASAL EUDAMED
- Model / Reference
- B606101 EUDAMEDA6061253 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861680350 EUDAMED06973861680299 EUDAMED06973861680473 EUDAMED
- Basic UDI-DI
- B-06973861680350 EUDAMEDB-06973861680299 EUDAMEDB-06973861680473 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass 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
Yes
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Boiron by Anbio (Xiamen) Biotechnology Co., Ltd. — Class IVD devices for self-testing — 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-06973861680350 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Anbio (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023936
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 0ea994f0-ef0e-41b4-94d7-a51d547e43ee 61 fields · synced Jul 26, 2026
- EUDAMED 328ac499-ab17-4c59-b22e-33c2f0c70347 61 fields · synced May 18, 2026
- EUDAMED 08ae099a-2c9a-40e3-bed6-4c79fa2a926a 61 fields · synced May 19, 2026