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Enterprise 5000x

EUDAMED

Class I (EU MDR)

Ref E5X3FA013DFANAModel 8X13GY113DCABARef E5X3BC006ACBOATRef E5X1BB001ABABBRef E5X3PH113DEDBARef E5X3QG003BFAZARef E5X3OG117CCAAARef E5X2HH103BAAAARef E5X2PG103DCAAARef E5X1BA111ABACBRef E5X3HL133BCAHBRef E5X3AL006AEABARef E5X3FA003DEBOARef E5X1DG111AAAAARef E5X3OR136CFDBARef E5X2PA103BEBOARef E5X3Q5003BFDDBRef E5X3NY006ACAZARef E5X3BC016CCABARef E5X3PR133DFDBARef E5X3FL003BBABARef E5X2QW113BEBVBRef E5X3QQ113BCAHBRef E5X2PC103DAABARef E5X3DR117ABDAARef E5X3BG006ADBOARef E5X1AC001ABBOARef E5X3OY118CEDBARef E5X3NQ138CFDBARef E5X3YQ117ACDAARef E5X3PL003BBBOARef E5X3DR117CADAARef E5X3NR116AFAVBRef E5X1BG001ACAJARef E5X3N0028AAAZARef E5X3DR117CFDAARef E5X1BN111CDBNBRef E5X3PC103BCABARef E5X2HQ113BFABARef E5X2EA013BBBOARef E5X1AA001ABBOARef E5X1BD101ABADARef E5X1BJ001EECGBRef E5X2EU003BBBOARef E5X1AW000ABBOARef E5X3FC003BCBOASRef E5X1CS111ACAJARef E5X3BC016AFANBRef E5G3YQ118CFDBARef E5X2HC103BBABARef E5X1V5134CDBNBRef E5X3BC006ACBOARef E5X3HQ113BFABA

by ArjoHuntleigh AB

Identity

Trade Name
ENTERPRISE 5000X EUDAMED
Device Name
ENTERPRISE 8000X EUDAMED
Model / Reference
8X13GY113DCABA EUDAMED
E5X3FA013DFANA EUDAMED
E5X3BC006ACBOAT EUDAMED
E5X1BB001ABABB EUDAMED
E5X3PH113DEDBA EUDAMED
E5X3QG003BFAZA EUDAMED
E5X3OG117CCAAA EUDAMED
E5X2HH103BAAAA EUDAMED
E5X2PG103DCAAA EUDAMED
E5X1BA111ABACB EUDAMED
E5X3HL133BCAHB EUDAMED
E5X3AL006AEABA EUDAMED
E5X3FA003DEBOA EUDAMED
E5X1DG111AAAAA EUDAMED
E5X3OR136CFDBA EUDAMED
E5X2PA103BEBOA EUDAMED
E5X3Q5003BFDDB EUDAMED
E5X3NY006ACAZA EUDAMED
E5X3BC016CCABA EUDAMED
E5X3PR133DFDBA EUDAMED
E5X3FL003BBABA EUDAMED
E5X2QW113BEBVB EUDAMED
E5X3QQ113BCAHB EUDAMED
E5X2PC103DAABA EUDAMED
E5X3DR117ABDAA EUDAMED
E5X3BG006ADBOA EUDAMED
E5X1AC001ABBOA EUDAMED
E5X3OY118CEDBA EUDAMED
E5X3NQ138CFDBA EUDAMED
E5X3YQ117ACDAA EUDAMED
E5X3PL003BBBOA EUDAMED
E5X3DR117CADAA EUDAMED
E5X3NR116AFAVB EUDAMED
E5X1BG001ACAJA EUDAMED
E5X3N0028AAAZA EUDAMED
E5X3DR117CFDAA EUDAMED
E5X1BN111CDBNB EUDAMED
E5X3PC103BCABA EUDAMED
E5X2HQ113BFABA EUDAMED
E5X2EA013BBBOA EUDAMED
E5X1AA001ABBOA EUDAMED
E5X1BD101ABADA EUDAMED
E5X1BJ001EECGB EUDAMED
E5X2EU003BBBOA EUDAMED
E5X1AW000ABBOA EUDAMED
E5X3FC003BCBOAS EUDAMED
E5X1CS111ACAJA EUDAMED
E5X3BC016AFANB EUDAMED
E5G3YQ118CFDBA EUDAMED
E5X2HC103BBABA EUDAMED
E5X1V5134CDBNB EUDAMED
E5X3BC006ACBOA EUDAMED
E5X3HQ113BFABA EUDAMED

Identifiers

Primary DI / UDI-DI
05056097356365 EUDAMED
05059441144472 EUDAMED
05055982750165 EUDAMED
05056097354903 EUDAMED
05059441129097 EUDAMED
05056097315324 EUDAMED
05059441129516 EUDAMED
05059441000952 EUDAMED
05055982750202 EUDAMED
05059441129028 EUDAMED
05059441149026 EUDAMED
05055982746397 EUDAMED
05056341699859 EUDAMED
05056097365916 EUDAMED
05055982747318 EUDAMED
05059441129080 EUDAMED
05056097359731 EUDAMED
05055982746892 EUDAMED
05056097331072 EUDAMED
05059441139850 EUDAMED
05055982747103 EUDAMED
05056097355375 EUDAMED
05055982747301 EUDAMED
05055982746588 EUDAMED
05059441130598 EUDAMED
05055982750790 EUDAMED
05056097323299 EUDAMED
05056097346533 EUDAMED
05059441129660 EUDAMED
05056097348995 EUDAMED
05055982746533 EUDAMED
05056097329581 EUDAMED
05055982749794 EUDAMED
05056097338682 EUDAMED
05055982746489 EUDAMED
05056097342542 EUDAMED
05055982745970 EUDAMED
05055982747363 EUDAMED
05055982748087 EUDAMED
05055982751025 EUDAMED
05055982749848 EUDAMED
05055982749756 EUDAMED
05055982747905 EUDAMED
05055982750448 EUDAMED
05059441144601 EUDAMED
05056097319285 EUDAMED
05056097331515 EUDAMED
05056097346519 EUDAMED
05055982747462 EUDAMED
05059441021902 EUDAMED
05056097340432 EUDAMED
05056097313740 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
Czechia EUDAMED
Poland EUDAMED
France EUDAMED
Austria EUDAMED
Italy EUDAMED
Ireland EUDAMED
Germany EUDAMED
Spain EUDAMED
Croatia EUDAMED
Romania EUDAMED
Malta EUDAMED
Belgium EUDAMED
Sweden EUDAMED
Netherlands EUDAMED
Lithuania 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (52)

  • EUDAMED 6727d576-c6c3-48ce-8dc5-16a2ab516386 61 fields · synced Sep 30, 2026
  • EUDAMED b320cb17-a636-44bb-bb32-c1737cfc5a86 61 fields · synced May 11, 2026
  • EUDAMED 224bcbc6-2c7b-4ffb-bb96-2c2684988925 61 fields · synced May 16, 2026
  • EUDAMED e0b1de2c-a65b-432e-9550-ef8d088c73bf 61 fields · synced May 16, 2026
  • EUDAMED 1f2f97f6-0b23-4a85-9da2-d908e0804a6c 61 fields · synced May 16, 2026
  • EUDAMED 845738b2-8467-4d2f-8519-caf82c82cc18 61 fields · synced May 16, 2026
  • EUDAMED 5f8a6e78-412f-42b4-ae7c-8c851e034b30 61 fields · synced May 16, 2026
  • EUDAMED bd576247-aabc-47ef-8db0-99af1f2222d7 61 fields · synced May 16, 2026
  • EUDAMED b01190f2-d01e-4474-91ec-331248e3a53e 61 fields · synced May 16, 2026
  • EUDAMED 14cff883-8fa7-4528-8a8b-5ceb45fd2781 61 fields · synced May 17, 2026
  • EUDAMED d6efe3bb-9ca8-44a3-a8b9-375badf1a20c 61 fields · synced May 17, 2026
  • EUDAMED 742b3089-e493-4c6f-a4fa-caa2d63acd2e 61 fields · synced May 17, 2026
  • EUDAMED 44ea5b9f-1d36-4316-851c-8a87d89d8c45 61 fields · synced May 17, 2026
  • EUDAMED 83c40557-8cc9-4a98-87e5-4924bc38433a 61 fields · synced May 17, 2026
  • EUDAMED 035ab92f-d711-4d9c-9af7-f0469650deb1 61 fields · synced May 17, 2026
  • EUDAMED ce46f3e3-eabb-44ce-bb76-79788219123e 61 fields · synced May 17, 2026
  • EUDAMED dcc750a7-afa4-47d7-bf5a-96ad018bec07 61 fields · synced May 17, 2026
  • EUDAMED 847e8cf8-2aae-4602-90f3-fa551adb72b5 61 fields · synced May 17, 2026
  • EUDAMED 04f9ddac-7a14-4f4e-aa56-dba994869828 61 fields · synced May 17, 2026
  • EUDAMED 0877b187-becd-4952-8110-1b8cec6fdf3f 61 fields · synced May 17, 2026
  • EUDAMED 2e4fe679-0818-4027-8603-15297991c3be 61 fields · synced May 17, 2026
  • EUDAMED 4458353e-1c33-46de-a1ed-17c105c17822 61 fields · synced May 17, 2026
  • EUDAMED adb73b2d-8ea5-4c21-bd4c-4bb4c2975257 61 fields · synced May 17, 2026
  • EUDAMED 15342303-a79c-46b4-8228-bd31c9e9036c 61 fields · synced May 17, 2026
  • EUDAMED c5c2e3e8-fa98-4c06-9482-eeee20b1ec54 61 fields · synced May 17, 2026
  • EUDAMED c667ce0e-a52a-4932-af39-9fbf72cefc58 61 fields · synced May 18, 2026
  • EUDAMED 9bf09972-4a1c-40e2-8441-e94bba7986a3 61 fields · synced May 18, 2026
  • EUDAMED 6582e6a9-63dc-4b96-8270-4fb3f00b3652 61 fields · synced May 18, 2026
  • EUDAMED 2bf1bd1c-1213-4bae-8b19-a6b6d8600ce4 61 fields · synced May 18, 2026
  • EUDAMED d2900533-48cb-4617-9d7f-935092f91706 61 fields · synced May 18, 2026
  • EUDAMED 098ada91-d8d5-4954-9e92-b7ff40589c2c 61 fields · synced May 18, 2026
  • EUDAMED 7ff43868-5576-4b79-8385-a877b3710d19 61 fields · synced May 18, 2026
  • EUDAMED 7a03434d-2d57-4495-9111-641ce59678a7 61 fields · synced May 18, 2026
  • EUDAMED fcda40d9-021d-43c7-a51f-22307e1c194d 61 fields · synced May 18, 2026
  • EUDAMED b67fc075-306d-4dc3-becc-d965bd8ffac8 61 fields · synced May 18, 2026
  • EUDAMED 20d49efc-4623-458c-ab1b-57052fb36924 61 fields · synced May 18, 2026
  • EUDAMED 1c6b11bc-78e8-4849-9051-1aeb50c0f136 61 fields · synced May 18, 2026
  • EUDAMED e0bd28c2-acb2-4e9f-bf60-2194f67c9477 61 fields · synced May 18, 2026
  • EUDAMED 1cfdfc89-1ff6-4064-b117-32fd5f8f45d4 61 fields · synced May 18, 2026
  • EUDAMED da7e58bf-3ec9-4189-92b7-82af6598efc9 61 fields · synced May 18, 2026
  • EUDAMED 7da37252-4261-47b4-abc1-bac41f6d4e54 61 fields · synced May 18, 2026
  • EUDAMED be6fc47a-c3d9-49e6-a7be-9fbf7c97497e 61 fields · synced May 18, 2026
  • EUDAMED db9a3aa0-bcda-4ac8-aee6-fe84ce2485f5 61 fields · synced May 18, 2026
  • EUDAMED db1b6e3f-0df2-434c-a8d3-7434c1dcdd2d 61 fields · synced May 18, 2026
  • EUDAMED 642f6d34-d254-40d2-9b2f-60570c5d95e0 61 fields · synced May 18, 2026
  • EUDAMED e8879dc7-2297-44d7-8b73-85cb6ae4d676 61 fields · synced May 18, 2026
  • EUDAMED d0c2a269-000e-4f15-a3e3-2f482dd93099 61 fields · synced May 19, 2026
  • EUDAMED dcd2db38-4d2a-4332-a0af-cb597473a048 61 fields · synced May 19, 2026
  • EUDAMED e044743e-bde2-417d-afa8-3c30e2c53d46 61 fields · synced May 19, 2026
  • EUDAMED bff5d5f8-3313-4928-96bd-0e7cf1b5ead9 61 fields · synced May 19, 2026
  • EUDAMED 06923af9-c8cd-4e48-ad87-d9105182292e 61 fields · synced May 19, 2026
  • EUDAMED 6097761d-b4f2-4785-919e-28628e3c961f 61 fields · synced May 19, 2026