Identity
- Trade Name
- Performix Pulsar EUDAMED
- Device Name
- Performix EUDAMED
- Model / Reference
- 5886600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278494542 EUDAMED
- Basic UDI-DI
- 8406821BUG00243H8 EUDAMED
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Performix Pulsar by GE Medical Systems, LLC — 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 | 8406821BUG00243H8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000001861
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 12625f27-4551-4905-976a-e67645c00304 61 fields · synced Jul 9, 2026