Identity
- Trade Name
- Laryngeal Mask Airway EUDAMED
- Device Name
- Laryngeal Mask Airway EUDAMED
- Model / Reference
- TPE EUDAMEDDY00020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941850887035 EUDAMED
- Basic UDI-DI
- 69418508TPE6E EUDAMED
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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: Laryngeal mask airway, single-use
Laryngeal Mask Airway by Ningbo Huakun Medical Equipment Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69418508TPE6E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Huakun Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008459
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6923e1a0-5a4d-4976-a37f-7b550bfb3d8a 61 fields · synced Jul 11, 2026