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Hollister

by Hollister Incorporated EUDAMED

Active European Union

Ref 54200, 2919135, 53900, 24503, 1448, 7600124, 17600, 2683051, 17200, 64300, 29740, 88144, 5691025, 26835, 7012, 3591, 73124, 54335, 140122, 94084, 20070, 534200, 14500S, 92104, 17200S, 9781, 27890, 97132, 9035, 22130, 3193S, 9431-30, 28340, 22135, 26800, 82081, 94142, 97129-15, 53735, 37000, 24790, 2949120, 14100, 64335, 24762, 149129, 28200, 14600, 22335

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number610075D01P040S00046Q Basic UDI-DIDate21 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
1-Piece Drainable Ostomy Pouch, CeraPlus
1-Piece Urostomy Pouch, Softflex
1-Piece Drainable Ostomy Pouch, CeraPlus, Convex
2-Piece Ostomy Pouch System, CeraPlus, Convex, Closed
1-Piece Urostomy Pouch, FlexWear
No Touch Urethral Intermittent Catheter, Nelaton
2-Piece Ostomy Skin Barrier, CeraPlus, Convex
1-Piece Drainable Ostomy Pouch, Softflex, Convex
2-Piece Ostomy Skin Barrier, CeraPlus
1-Piece Urostomy Pouch, Flextend, Convex
Hydrophilic Urethral Intermittent Catheter
1-Piece Drainable Ostomy Pouch, FlexWear, Soft Convex
1-Piece Closed Ostomy Pouch, Softflex, Convex
No Touch Urethral Intermittent Catheter, Tiemann
Pre-lubricated Urethral Intermittent Catheter with Integrated Collection Bag, Nelaton
1-Piece Post-Op Ostomy Pouch, FlexWear
Pre-lubricated Urethral Intermittent Catheter Nelaton
Horizontal Drain/Tube Attachment Device - Sterile
2-Piece Urostomy Pouch
Male Incontinence Sheath (Catheter)
Urinary Leg Bags
1-Piece Closed Ostomy Pouch, Softflex
Urinary Night Drainage Bags
1-Piece Drainable Ostomy Pouch, Softflex
2-Piece Ostomy Skin Barrier, Flextend, Convex
1-Piece Urostomy Pouch, Flextend
2-Piece Ostomy Pouch System, SoftFlex, Drainable
Model / Reference
54200, 2919135, 53900, 24503, 1448, 7600124, 17600, 2683051, 17200, 64300, 29740, 88144, 5691025, 26835, 7012, 3591, 73124, 54335, 140122, 94084, 20070, 534200, 14500S, 92104, 17200S, 9781, 27890, 97132, 9035, 22130, 3193S, 9431-30, 28340, 22135, 26800, 82081, 94142, 97129-15, 53735, 37000, 24790, 2949120, 14100, 64335, 24762, 149129, 28200, 14600, 22335
Primary DI / UDI-DI
00610075057924, 00610075198009, 00610075057757, 00610075093168, 05390166028242, 00610075092680, 05390166173294, 05390166167521, 05390166168337, 00610075057399, 00610075058693, 00610075161379, 00610075072217, 05390166164063, 05390166070562, 00610075063598, 00610075080038, 00610075205967, 00610075057993, 00610075072811, 00610075081875, 00610075106653, 00610075087181, 00610075084951, 00610075081677, 00610075085026, 00610075103591, 00610075189946, 00610075971329, 05390166080981, 00610075221301, 00610075084661, 05390166081223, 05390166056061, 00610075221356, 05390166131591, 00610075072453, 00610075081950, 00610075070664, 00610075057740, 00610075206858, 00610075050871, 00610075198139, 00610075057221, 00610075058723, 00610075113897, 00610075030033, 00610075062416, 05390166055620, 05390166173270, 00610075223350
Basic UDI-DI
610075D01P040S00046Q, 610075D01P044S00478W, 610075D01P040S004678, 610075D01P087S0347CQ, 610075D01P044S00558V, 610075D03P092S0368DA, 610075D01P064S0086AA, 610075D01P040S00016J, 610075D01P064S0085A8, 610075D01P044S00518M, 610075D03P088S0174EQ, 610075D01P040S00086Y, 610075D03P089S0194FB, 610075D01P038S0039A2, 610075D03P081S0259C6, 610075D03P007S0248A7, 610075D01P023S00297D, 610075D03P005S02479B, 610075D04P062S0275CC, 610075D02P072S0112A6, 610075D01P030S00586W, 610075D03P016S02259X, 610075D01P038S00409K, 610075D01P038S00389Y, 610075D03P016S02249V, 610075D01P040S00026L, 610075D03P090S0173BX, 610075D01P064S0084A6, 610075D01P044S00508K, 610075D01P087S0187CS
Unit of Use DI
20610075057928, 00610075077373, 00610075078295, 30610075245032, 35390166028243, 20610075092684, 00610075075669, 35390166167522, 00610075075645, 20610075058697, 00610075077762, 00610075080571, 00610075078943, 25390166070566, 00610075066100, 20610075080032, 00610075065479, 20610075057997, 20610075072815, 00610075063147, 30610075106654, 20610075087185, 00610075065660, 00610075082445, 00610075077038, 30610075971320, 00610075094288, 00610075076376, 35390166081224, 00610075076611, 00610075076383, 00610075076857, 00610075069323, 00610075063277, 20610075070668, 20610075057744, 30610075206859, 00610075076710, 00610075077571, 00610075074235, 20610075058727, 30610075113898, 20610075062410, 00610075077052, 00610075074525, 00610075076451
EMDN Code
A1001010102, A1001030102, A1001010202, A1099, U01010501, A1002010402, A1002010401, A1001030202, U01010601, A0380, A10020402, U070201, A06030301
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000027818
Authorised representative
Hollister ULC IE-AR-000022119

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Sterile NoEUDAMEDYesEUDAMED

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No