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Disposable Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref DM010250Model Disposable Medical Face Mask
Identity
- Trade Name
- Disposable Medical Face Mask EUDAMED
- Device Name
- Disposable Medical Face Mask EUDAMED
- Model / Reference
- Disposable Medical Face Mask EUDAMEDDM010250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970969869267 EUDAMED
- Basic UDI-DI
- 697096986053M EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Disposable Medical Face Mask by Zhejiang Longde Pharmaceutical Co., Ltd. — Class I — 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 | 697096986053M | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Longde Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021623
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 15c940ef-74c5-4ee2-b5a0-336e47a50d92 61 fields · synced Jun 19, 2026