Identity
- Trade Name
- Plain Pouch With Rebreath EUDAMED
- Device Name
- CPR Face Shields EUDAMED
- Model / Reference
- TF32 EUDAMED855 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060131888552 EUDAMED
- Basic UDI-DI
- 506013188TF323P EUDAMED
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES 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
Plain Pouch With Rebreath by Reliance Medical 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 | 506013188TF323P | Class I | Active |
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Manufacturer
- Manufacturer
- Reliance Medical Ltd
- EUDAMED SRN
- GB-MF-000004799
- Authorised Representative
- Reliance Medical (Ireland) IE-AR-000003675
Sources (1)
- EUDAMED 9b135742-343f-4ac3-afcf-e705b19775fa 61 fields · synced Jun 19, 2026