Identity
- Trade Name
- Performix HD Plus EUDAMED
- Device Name
- Performix EUDAMED
- Model / Reference
- 5970000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682134798 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 HD Plus 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 95cd050c-860c-4694-9cc7-b39ed2e087b6 61 fields · synced Jul 12, 2026