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Enterprise 8000x
EUDAMEDClass I (EU MDR)
Ref 8X24GM103BFAHBModel 8X13GY113DCABARef 8X23HP103BDABARef 8X23TC113DFDAARef 8X23GB113DAAAARef 8X23O3003FFAZARef 8X23OL113BDDAARef 8X24GU00ABDBOARef 8X24UG013DCDSARef 8X23GC103BBAAARef 8X23HU103DEABARef 8X23GC113BAAAARef 8X23HQ113BAACARef 8X23VG003BCAHARef 8X23HQ013BBDYBRef 8X23GQ123BEAHARef 8X23OG103BAABARef 8X23UQ113BFABARef 8X23GQ103BFAHBRef 8X24GL103BEAHBRef 8X23GY103BFBOARef 8X23GZ113FFAZARef 8X23GA003BBABARef 8X23OU103BEADARef 8X23GZ113BDACA
Identity
- Trade Name
- ENTERPRISE 8000X EUDAMED
- Device Name
- ENTERPRISE 8000X EUDAMED
- Model / Reference
- 8X13GY113DCABA EUDAMED8X24GM103BFAHB EUDAMED8X23HP103BDABA EUDAMED8X23TC113DFDAA EUDAMED8X23GB113DAAAA EUDAMED8X23O3003FFAZA EUDAMED8X23OL113BDDAA EUDAMED8X24GU00ABDBOA EUDAMED8X24UG013DCDSA EUDAMED8X23GC103BBAAA EUDAMED8X23HU103DEABA EUDAMED8X23GC113BAAAA EUDAMED8X23HQ113BAACA EUDAMED8X23VG003BCAHA EUDAMED8X23HQ013BBDYB EUDAMED8X23GQ123BEAHA EUDAMED8X23OG103BAABA EUDAMED8X23UQ113BFABA EUDAMED8X23GQ103BFAHB EUDAMED8X24GL103BEAHB EUDAMED8X23GY103BFBOA EUDAMED8X23GZ113FFAZA EUDAMED8X23GA003BBABA EUDAMED8X23OU103BEADA EUDAMED8X23GZ113BDACA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056097336770 EUDAMED05055982752510 EUDAMED05056097345451 EUDAMED05056341699989 EUDAMED05059441141761 EUDAMED05059441129684 EUDAMED05059441149156 EUDAMED05059441136460 EUDAMED05055982751438 EUDAMED05055982783965 EUDAMED05055982751612 EUDAMED05055982758062 EUDAMED05059441148432 EUDAMED05056097332789 EUDAMED05059441126317 EUDAMED05056097313368 EUDAMED05056097341101 EUDAMED05056097357003 EUDAMED05056097327143 EUDAMED05056097335155 EUDAMED05055982752206 EUDAMED05056097323732 EUDAMED05056097329253 EUDAMED05055982752190 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
- Spain EUDAMEDFrance EUDAMEDGermany EUDAMEDIreland EUDAMEDItaly EUDAMEDPoland EUDAMEDAustria EUDAMEDCyprus EUDAMEDNetherlands 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 8000x 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 (24)
- EUDAMED f00a1943-b4d0-4abe-88ea-8d473c771bfd 61 fields · synced Sep 18, 2026
- EUDAMED 4b6ad9a6-e067-4a84-bd2c-cd618764caa6 61 fields · synced May 16, 2026
- EUDAMED ebc56656-1430-48a0-ae65-9037d2cad08e 61 fields · synced May 16, 2026
- EUDAMED 72fecb98-74d5-4292-8657-bbdc7e195f16 61 fields · synced May 16, 2026
- EUDAMED d2f1837a-50c3-4b82-96e0-29dcfc39d841 61 fields · synced May 16, 2026
- EUDAMED d7f76ce0-073d-497a-b267-b0318b02051f 61 fields · synced May 16, 2026
- EUDAMED b1396912-c5ba-4485-b78b-a0832b69445a 61 fields · synced May 17, 2026
- EUDAMED 6e7232ef-4738-4ca2-a9af-763b71bc48a7 61 fields · synced May 17, 2026
- EUDAMED cbfc6651-c95c-4799-a287-23a6b28b1de3 61 fields · synced May 17, 2026
- EUDAMED eef0924b-2662-4276-9434-74acf9e42302 61 fields · synced May 17, 2026
- EUDAMED 83ea71f1-9939-493f-955e-2876a0f63840 61 fields · synced May 17, 2026
- EUDAMED 05fa20d9-28d8-436b-a05b-dc92578d6577 61 fields · synced May 17, 2026
- EUDAMED 5052dad2-59a3-46bb-808b-49c884ce4864 61 fields · synced May 17, 2026
- EUDAMED d7d9c230-a123-4117-ab6d-ef9ae590516a 61 fields · synced May 18, 2026
- EUDAMED 67021a90-e8c9-41f5-b9b7-ec5ede7ae3aa 61 fields · synced May 18, 2026
- EUDAMED c16afdb5-b9ab-4fb4-b569-a11266a42fe4 61 fields · synced May 18, 2026
- EUDAMED dccec12e-9ca9-499e-b234-b66eea5cda93 61 fields · synced May 18, 2026
- EUDAMED aa83556e-0e66-437f-9733-67e6717fefc9 61 fields · synced May 18, 2026
- EUDAMED d54500fa-0187-4477-84b0-4b74b48792c7 61 fields · synced May 18, 2026
- EUDAMED 8adb4f6a-025c-4731-99b7-64c61b4a0fec 61 fields · synced May 18, 2026
- EUDAMED 6463c5fb-dbad-4c4c-8913-166ce6d1940d 61 fields · synced May 18, 2026
- EUDAMED 91172ec2-6b8f-44a9-9113-9cb3c91cd48f 61 fields · synced May 19, 2026
- EUDAMED 740af662-54c9-4b32-b3af-97e414974bee 61 fields · synced May 19, 2026
- EUDAMED a0a5563d-a060-47ed-a7e5-6ad8ca87a840 61 fields · synced May 19, 2026