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ComfortHeal Biodegarabale Ostomy Liner Regular Size
EUDAMEDClass I (EU MDR)
Ref OPL2Model OPL2 RegularSize
Identity
- Trade Name
- ComfortHeal Biodegarabale Ostomy Liner Regular Size EUDAMED
- Model / Reference
- OPL2 RegularSize EUDAMEDOPL2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809964140010 EUDAMED
- Basic UDI-DI
- 880996414OPL2SR 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
- Northern 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
ComfortHeal Biodegarabale Ostomy Liner Regular Size by GHC 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 | 880996414OPL2SR | Class I | Active |
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Manufacturer
- Manufacturer
- GHC Co., Ltd.
- EUDAMED SRN
- KR-MF-000043303
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED f72a2518-0b25-4404-badb-2deddcb3aa71 61 fields · synced Jul 15, 2026