Identity
- Trade Name
- Disposable Anesthetic Masks EUDAMED
- Device Name
- Disposable Anesthetic Masks EUDAMED
- Model / Reference
- B EUDAMED2103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941850831205 EUDAMED
- Basic UDI-DI
- 69418508DAM02LG EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Anaesthesia face mask, single-use
Disposable Anesthetic Masks by Ningbo Huakun Medical Equipment Co., Ltd — 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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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 | 69418508DAM02LG | 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 c3ead1c3-27c9-4a6e-bd53-d833fca3f294 61 fields · synced Jun 19, 2026