Identity
- Trade Name
- STARICARE EUDAMED
- Device Name
- Ostomy Bag EUDAMED
- Model / Reference
- One-piece Ostomy Bag EUDAMEDY1118A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935104500665 EUDAMED
- Basic UDI-DI
- 69351045Ostomy-Bag2M 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
Staricare by Hubei Hendry Medical Appliance Co., 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 | 69351045Ostomy-Bag2M | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hubei Hendry Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000012337
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED cad8122a-c707-4955-85ec-769436a7850e 61 fields · synced Jul 14, 2026