Identity
- Trade Name
- Zorbo Gauze Balls EUDAMED
- Device Name
- Cotton Wool Ball EUDAMED
- Model / Reference
- 1SGB002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055141581708 EUDAMED
- Basic UDI-DI
- 50551416328178 EUDAMED
- EMDN Code
- M010102 PURE COTTON EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Zorbo Gauze Balls by Millpledge Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50551416328178 | Class I | No Longer Active |
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Manufacturer
- Manufacturer
- Millpledge Ltd
- EUDAMED SRN
- GB-MF-000018081
- Authorised Representative
- Millpledge Europe BV BE-AR-000016200
Sources (1)
- EUDAMED 30fb472b-0f17-4eee-87f2-0dd19b90941d 61 fields · synced Jun 18, 2026