Identity
- Trade Name
- Guardix SG EUDAMED
- Device Name
- GUARDIX SG EUDAMED
- Model / Reference
- GUARDIX-SGn-030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809275770609 EUDAMED
- Basic UDI-DI
- 8809275770001CB EUDAMED
- EMDN Code
- M0406 DRESSINGS FOR THE PREVENTION OF POST-OPERATIVE ADHESIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
Yes
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
Guardix SG by Genewel Co., Ltd. — Class IIb — 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 | 8809275770001CB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Genewel Co., Ltd.
- EUDAMED SRN
- KR-MF-000019878
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 4dd2fc88-c79d-420d-8e1f-a9d0d94a1d99 61 fields · synced Jun 17, 2026