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Oxygen Masks

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref IIa，rule 2Model Simple oxygen mask and Venturi mask（XL，L，M，S）；Oxygen mask with reservoir bag（XXL，XL，L，M，S，XS）；Aerosol mask（XL，L，M，S）510(k) K142764Ref IIa,rule 2Model CPR Mask with oxygen inlet；CPR Mask without oxygen inlet

by Hangzhou Jinlin Medical Appliances Co., Ltd.

Identity

Device Name
Oxygen Masks EUDAMED
CPR Masks EUDAMED
Model / Reference
Simple oxygen mask and Venturi mask（XL，L，M，S）；Oxygen mask with reservoir bag（XXL，XL，L，M，S，XS）；Aerosol mask（XL，L，M，S） EUDAMED
IIa，rule 2 EUDAMED
CPR Mask with oxygen inlet；CPR Mask without oxygen inlet EUDAMED
IIa,rule 2 EUDAMED

Identifiers

Primary DI / UDI-DI
06946594901108 EUDAMED
Basic UDI-DI
69465949HXOAH EUDAMED
69465949CPR96 EUDAMED
510(k) Number
K142764 FDA 510(k)
FDA Product Code
CBP FDA 510(k)
EMDN Code
R03010201 AIR/OXYGEN MASKS EUDAMED
R03010101 ANAESTHETIC FACE MASKS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5870 FDA 510(k)
Regulation Number
868.5870 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

Oxygen Masks by Hangzhou Jinlin Medical Appliances Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hangzhou Jinlin Medical Appliances Co., Ltd.
EUDAMED SRN
CN-MF-000012391
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 9e1bed3a-4e1f-4951-8993-5ca5d3169d8b 61 fields · synced Oct 7, 2026
  • FDA 510(k) K142764 24 fields · synced May 18, 2026
  • EUDAMED 02cd32a8-1e28-418e-acdf-0ed646a0557d-1 61 fields · synced Jul 8, 2026
  • EUDAMED 02cd32a8-1e28-418e-acdf-0ed646a0557d-2 61 fields · synced Jul 8, 2026