Identity
- Trade Name
- SW HMSC 3.65 EUDAMED
- Model / Reference
- HMSC EUDAMED496631 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035479189235 EUDAMED
- Basic UDI-DI
- 4035479BUDI00002PN EUDAMED
- Direct Marketing DI
- 04035479189235 EUDAMED
- EMDN Code
- J010792 ACTIVE IMPLANTABLE CARDIAC DEVICES REMOTE MONITORING SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sw Hmsc 3.65 by BIOTRONIK SE & Co. KG — Class III — 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 | 4035479BUDI00002PN | Class III | Active |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
- EUDAMED SRN
- DE-MF-000005049
Sources (1)
- EUDAMED f6ddb76b-6d5f-4107-bf2f-582905ae163f 61 fields · synced Jul 25, 2026