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Enterprise 5000x
EUDAMEDClass I (EU MDR)
Ref E5X1DD101ACAAAModel 8X13GY113DCABA
Identity
- Trade Name
- ENTERPRISE 5000X EUDAMED
- Device Name
- ENTERPRISE 8000X EUDAMED
- Model / Reference
- 8X13GY113DCABA EUDAMEDE5X1DD101ACAAA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055982749220 EUDAMED
- Basic UDI-DI
- 5060693520143VW EUDAMED
- EMDN Code
- V08060103 SEMI-INTENSIVE THERAPY OR CARDIAC INTENSIVE CARE UNITS (CICU) ELECTRIC MEDICAL BEDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Enterprise 5000x by Arjohuntleigh AB — 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 | 5060693520143VW | Class I | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (1)
- EUDAMED 0cfba6ce-3c61-41f7-9c91-c2fa2d4373f6 61 fields · synced Jun 18, 2026