Identity
- Device Name
- Conforming Gauze Roll EUDAMED
- Model / Reference
- EU-9027124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01230000233064 EUDAMED
- Basic UDI-DI
- 1230000233EU-9027124DF EUDAMED
- EMDN Code
- M020107 COTTON GAUZES IN ROLLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Conforming Gauze Roll by Healqu Llc. — 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 | 1230000233EU-9027124DF | Class I | Active |
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Manufacturer
- Manufacturer
- Healqu Llc.
- EUDAMED SRN
- US-MF-000037517
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED 96b0612a-1a61-4673-8c1a-050e9a1ea7ce 61 fields · synced Aug 2, 2026