Identity
- Trade Name
- Plate Barrier Envelope EUDAMED
- Device Name
- Plate Barrier Envelope EUDAMED
- Model / Reference
- Size 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883022097 EUDAMED
- Basic UDI-DI
- 471988302ENVELOPEDX EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Plate Barrier Envelope by Dhef Inc. — 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 | 471988302ENVELOPEDX | Class I | Active |
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Manufacturer
- Manufacturer
- Dhef Inc.
- EUDAMED SRN
- TW-MF-000008480
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 29ab6dcd-dc04-48cc-a8b2-287937785727 61 fields · synced Jun 18, 2026