Identity
- Trade Name
- Instrapac 8-Ply Gauze Swabs BP EUDAMED
- Device Name
- Woven Swabs EUDAMED
- Model / Reference
- 5910 EUDAMED5911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05010058059108 EUDAMED05010058059115 EUDAMED
- Basic UDI-DI
- 5010058C1nT005G00AY6 EUDAMED
- EMDN Code
- M0201020102 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Instrapac 8-Ply Gauze Swabs BP by Robinson Healthcare 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 | 5010058C1nT005G00AY6 | Class I | Active |
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Manufacturer
- Manufacturer
- Robinson Healthcare Ltd
- EUDAMED SRN
- GB-MF-000016546
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 60ba4fe4-ce2c-4372-8f52-6fe5217b35ef 61 fields · synced Jul 14, 2026
- EUDAMED a2519d48-45ad-4808-b423-0ce1540e960c 61 fields · synced May 19, 2026