Identity
- Trade Name
- PK-128/2,8m EUDAMED
- Model / Reference
- Stimulation cable EUDAMED339818 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035479061524 EUDAMED
- Basic UDI-DI
- 4035479BUDI00094QM EUDAMED
- Direct Marketing DI
- 04035479061524 EUDAMED
- EMDN Code
- Z1205078099 INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - HARDWARE ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
PK-128/2, 8m by BIOTRONIK SE & Co. KG — Class I — 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 | 4035479BUDI00094QM | Class I | Active |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
- EUDAMED SRN
- DE-MF-000005049
Sources (1)
- EUDAMED 5a758d49-5711-454c-9dfe-1101f11657be 61 fields · synced Jul 12, 2026