Identity
- Trade Name
- Barrier Envelops EUDAMED
- Device Name
- Barrier Envelops EUDAMED
- Model / Reference
- SIZE 0 EUDAMEDSIZE 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800003010110 EUDAMED08800003010127 EUDAMED
- Basic UDI-DI
- 88000030RBE00135 EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS 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 Envelops by Ray Co., 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 | 88000030RBE00135 | Class I | Active |
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Manufacturer
- Manufacturer
- Ray Co., Ltd.
- EUDAMED SRN
- KR-MF-000007225
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 41bf8d19-0522-415c-850f-d9166e31b91b 61 fields · synced Jul 15, 2026
- EUDAMED 1cec5d6a-9643-46b2-a6a2-961138017495 61 fields · synced May 18, 2026