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Holter System
EUDAMEDClass IIa (EU MDR)
Ref G1101Model BI9100Ref BIP-01CModel 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-01CRef EP820-12Ref BI9800Ref BI6812Ref BIP-03BRef BIP-03ARef BI6603Ref BIP-01BRef EP820Ref BIP-03CRef EP830Ref G2801Model BI6800
Identity
- Trade Name
- Holter System EUDAMED
- Device Name
- Holter System EUDAMED
- Model / Reference
- BI9100 EUDAMEDG1101 EUDAMEDBI9900, 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 EUDAMEDBIP-01C EUDAMEDEP820-12 EUDAMEDBI9800 EUDAMEDBI6812 EUDAMEDBIP-03B EUDAMEDBIP-03A EUDAMEDBI6603 EUDAMEDBIP-01B EUDAMEDEP820 EUDAMEDBIP-03C EUDAMEDEP830 EUDAMEDBI6800 EUDAMEDG2801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912080299 EUDAMED06970912081234 EUDAMED06970912080794 EUDAMED06970912080374 EUDAMED06970912080398 EUDAMED06970912081197 EUDAMED06970912081180 EUDAMED06970912080428 EUDAMED06970912081227 EUDAMED06970912080787 EUDAMED06970912081203 EUDAMED06970912080800 EUDAMED06970912080480 EUDAMED
- Basic UDI-DI
- B-06970912080299 EUDAMED697091208AECGGJ EUDAMEDB-06970912080480 EUDAMED
- Direct Marketing DI
- 06970912081234 EUDAMED06970912080374 EUDAMED06970912080398 EUDAMED06970912081197 EUDAMED06970912081180 EUDAMED06970912080428 EUDAMED06970912081227 EUDAMED06970912081203 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDAustria EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Holter System by Biomedical Instruments Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970912080299 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970912080299 | 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 (13)
- EUDAMED a87a6958-584d-4ef1-b82e-507c5a4c35c8 61 fields · synced Oct 6, 2026
- EUDAMED ef5df00a-0da7-4585-8a1c-62e5c4f280df 61 fields · synced May 16, 2026
- EUDAMED 11be1732-6854-4483-8716-940fbae538b2 61 fields · synced May 17, 2026
- EUDAMED 7b8f8d92-99aa-452a-9ab1-59b5d2f2605d 61 fields · synced May 17, 2026
- EUDAMED ba1ccb52-3a63-4c17-af63-165ea0d23bd6 61 fields · synced May 17, 2026
- EUDAMED 9546436d-c436-46f3-8dd5-891913366584 61 fields · synced May 17, 2026
- EUDAMED 41dd53ae-4d01-4cb8-b306-28032790c30d 61 fields · synced May 17, 2026
- EUDAMED bce5b552-1d2c-4e63-b58c-16d1684a7e0f 61 fields · synced May 17, 2026
- EUDAMED 03d0c792-08a8-4cce-88ba-955905e8c0f7 61 fields · synced May 17, 2026
- EUDAMED 5dcabd76-b4de-49f1-9aa2-dc5678648b23 61 fields · synced May 17, 2026
- EUDAMED e51d0409-9dbb-4296-8472-69f252efee34 61 fields · synced May 18, 2026
- EUDAMED 0d1d641b-c06e-4e9c-9489-a4516331792c 61 fields · synced May 18, 2026
- EUDAMED b3cfd13a-189b-4730-999b-0786147872e0 61 fields · synced May 19, 2026