Identity
- Trade Name
- Hollister EUDAMED
- Device Name
- 1-Piece Drainable Ostomy Pouch, FlexWear, Soft Convex EUDAMED
- Model / Reference
- 5691120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05390166164094 EUDAMED
- Basic UDI-DI
- 610075D01P040S00086Y EUDAMED
- Unit of Use DI
- 00610075078974 EUDAMED
- EMDN Code
- A1001010202 ONE-PIECE COLOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER 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
Category: One-piece intestinal ostomy bag, closed-ended
Hollister by Hollister Incorporated — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as One-piece intestinal ostomy bag, closed-ended.
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- SenSura Mio Convex — Coloplast A/S · Class I
- SenSura Mio Concave — Coloplast A/S · Class I
- Dansac — Dansac A/S · Class I
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 | 610075D01P040S00086Y | Class I | Active |
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Manufacturer
- Manufacturer
- Hollister Incorporated
- EUDAMED SRN
- US-MF-000027818
- Authorised Representative
- Hollister ULC IE-AR-000022119
Sources (1)
- EUDAMED 49e39caf-122c-4528-b939-0d4175c6281e 61 fields · synced Jun 9, 2026