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Hollister

by Hollister Incorporated 117 variants

Part of a family of 7 devices: see the family pagePart of a family of 7 devices: see the family pagePart of a family of 15 devices: see the family page

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

Hollister (54200) is a Class I device made by Hollister Incorporated, registered in EUDAMED on 21 Mar 2025 (Basic UDI-DI 610075D01P040S00046Q), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number610075D01P040S00046Q Basic UDI-DI Date21 Mar 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

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

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Properties

  • Supplied sterile NoEUDAMEDYesEUDAMED
Other properties (13, all answered No)