Identity
- Trade Name
- Face mask for anesthesia EUDAMED
- Device Name
- Rüsch Face Mask Silicone EUDAMED
- Model / Reference
- 154900-000010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704737656 EUDAMED
- Basic UDI-DI
- 08019020000000000000184KV EUDAMED
- Direct Marketing DI
- 24026704737653 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Anaesthesia face mask, single-use
Face mask for anesthesia by Teleflex Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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 | 08019020000000000000184KV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (1)
- EUDAMED fd27fb24-8ddd-42db-8ed4-7e1ae1aa2bee 61 fields · synced Aug 2, 2026