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Qubic Stim - EP Heart Stimulator
EUDAMEDClass IIb (EU MDR)
Ref 396165Model Qubic Stim
Identity
- Trade Name
- Qubic Stim - EP Heart Stimulator EUDAMED
- Model / Reference
- Qubic Stim EUDAMED396165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035479133429 EUDAMED
- Basic UDI-DI
- 4035479BUDI00056QD EUDAMED
- Direct Marketing DI
- 04035479133429 EUDAMED
- EMDN Code
- Z1205078001 CARDIAC ELECTROPHYSIOLOGY STIMULATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Qubic Stim - EP Heart Stimulator by BIOTRONIK SE & Co. KG — Class IIb — 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 | 4035479BUDI00056QD | Class IIb | Active |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
- EUDAMED SRN
- DE-MF-000005049
Sources (1)
- EUDAMED d57f98e9-f1a1-4cfa-8c5c-e01c880971f2 61 fields · synced Jun 19, 2026