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Disposable Laryngeal Mask
EUDAMEDClass IIa (EU MDR)
Ref DLM1.0; DLM1.5; DLM2.0; DLM2.5; DLM3.0; DLM4.0; DLM5.0Model General Type
Identity
- Trade Name
- Disposable Laryngeal Mask EUDAMED
- Device Name
- Disposable Laryngeal Mask Airway EUDAMED
- Model / Reference
- General Type EUDAMEDDLM1.0; DLM1.5; DLM2.0; DLM2.5; DLM3.0; DLM4.0; DLM5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375391346 EUDAMED
- Basic UDI-DI
- B-06944375391346 EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable Laryngeal Mask by Zhejiang Haisheng Medical Device Co., Ltd. — 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-06944375391346 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 2fd6686e-875d-4975-8cd9-545bf9405a8b 61 fields · synced Jun 18, 2026
- EUDAMED 2fd6686e-875d-4975-8cd9-545bf9405a8b-1 61 fields · synced Jun 10, 2026