Identity
- Trade Name
- Barrier Envelope Size 2 EUDAMED
- Device Name
- Barrier Covers EUDAMED
- Model / Reference
- 17302Pegasus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060111782528 EUDAMED
- Basic UDI-DI
- 50601117812535171VK EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER 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
Barrier Envelope Size 2 by Astek Innovations 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 | 50601117812535171VK | Class I | Active |
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Manufacturer
- Manufacturer
- Astek Innovations Ltd
- EUDAMED SRN
- GB-MF-000013346
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (1)
- EUDAMED 8aee4e9d-42fe-40b5-b898-86911ffaf532 61 fields · synced Sep 18, 2026