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CPAP face mask

EUDAMED

Class IIa (EU MDR)

Ref 1603Ref 1601Ref 1633Ref 1611Ref 1612

by Da Chung Medical Co., Ltd.

Identity

Device Name
CPAP face mask EUDAMED
Model / Reference
1603 EUDAMED
1601 EUDAMED
1633 EUDAMED
1611 EUDAMED
1612 EUDAMED

Identifiers

Primary DI / UDI-DI
04719873291687 EUDAMED
04719873291663 EUDAMED
04719873292554 EUDAMED
04719873291724 EUDAMED
04719873291731 EUDAMED
Basic UDI-DI
47198732910VK EUDAMED
Direct Marketing DI
04719873291687 EUDAMED
04719873291663 EUDAMED
04719873292554 EUDAMED
04719873291724 EUDAMED
04719873291731 EUDAMED
EMDN Code
R0301010201 CPAP MASKS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Poland 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

CPAP face mask by Da Chung Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
TW-MF-000037960
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (5)

  • EUDAMED c395f2ce-438d-4641-a60e-9dfd92ceee07 61 fields · synced Aug 3, 2026
  • EUDAMED f21df004-c48a-4cef-b3ad-5eb71fef44e0 61 fields · synced May 17, 2026
  • EUDAMED ef500647-2c29-4d23-9fc2-b146f1da74ff 61 fields · synced May 17, 2026
  • EUDAMED da1f1664-9810-4223-a58e-8bfccdde31df 61 fields · synced May 17, 2026
  • EUDAMED 6d3882c9-54dd-4fcc-99ad-86a2dd491df3 61 fields · synced May 19, 2026