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Ostomy bag
EUDAMEDClass I (EU MDR)
Ref 0232Model 101040,101050,101055,101060,2041757,2039045,2039057,2139245,101085,111245,112245,19021912,0482,0232,0149,0313,0314,0371,3044,3045,3023,2131,2132,2071,2171,4043,22212255,0283,0287,0910,0352,0257,0903,0845,1845,0945,6106,6301,0379,0143,0432,Etc
Identity
- Trade Name
- Ostomy bag EUDAMED
- Device Name
- Ostomy bag EUDAMED
- Model / Reference
- 101040,101050,101055,101060,2041757,2039045,2039057,2139245,101085,111245,112245,19021912,0482,0232,0149,0313,0314,0371,3044,3045,3023,2131,2132,2071,2171,4043,22212255,0283,0287,0910,0352,0257,0903,0845,1845,0945,6106,6301,0379,0143,0432,Etc EUDAMED0232 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977524420017 EUDAMED
- Basic UDI-DI
- 697752442OstomybagMP EUDAMED
- EMDN Code
- A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Ostomy bag by BoyarGlanz Medical Equipment Ltd — 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 | 697752442OstomybagMP | Class I | Active |
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Manufacturer
- Manufacturer
- BoyarGlanz Medical Equipment Ltd
- EUDAMED SRN
- CN-MF-000052852
- Authorised Representative
- AION CIRCUITS, LDA PT-AR-000044689
Sources (1)
- EUDAMED a8b8df93-3e44-405c-bc88-11e8c4972100 61 fields · synced Jun 17, 2026