Identity
- Device Name
- Holter System EUDAMED
- Model / Reference
- BI9900 EUDAMEDG3101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912080305 EUDAMED
- Basic UDI-DI
- B-06970912080305 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Holter System by Biomedical Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970912080305 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomedical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000016483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d36f0a3c-64d1-4fdf-8f55-a4f98ba29054 61 fields · synced Oct 6, 2026