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"Fortune" Laryngeal Mask Tube (Non-Sterile)
EUDAMEDClass IIa (EU MDR)
Ref 1580-0050
Identity
- Trade Name
- "Fortune" Laryngeal Mask Tube (Non-Sterile) EUDAMED
- Device Name
- "Fortune" Laryngeal Mask Tube (Non-Sterile) EUDAMED
- Model / Reference
- 1580-0050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182603151 EUDAMED
- Basic UDI-DI
- B-04711182603151 EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
"Fortune" Laryngeal Mask Tube (Non-Sterile) by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182603151 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 87f28349-93e7-4962-a590-627a94c05070 61 fields · synced Oct 6, 2026