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Holter System
EUDAMEDClass IIa (EU MDR)
Ref BI9900Model BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C
Identity
- Trade Name
- Holter System EUDAMED
- Device Name
- Holter System EUDAMED
- Model / Reference
- BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C EUDAMEDBI9900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912080848 EUDAMED
- Basic UDI-DI
- 697091208AECGGJ EUDAMED
- Direct Marketing DI
- 06970912080848 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
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Holter System by Biomedical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697091208AECGGJ | Class IIa | Active |
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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 a3ee45da-9159-4636-9a61-fba6d870715c 61 fields · synced Jun 19, 2026