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Resuscitation Mask

EUDAMED

Class IIa (EU MDR)

Ref ERM0101001Model CP641011Ref ERM0101002Model CP641000Ref ERM0101003Ref FS-104Ref 500012

by Xiamen Compower Medical Tech. Co., Ltd.

Identity

Trade Name
Resuscitation Mask EUDAMED
Device Name
Resuscitation Mask EUDAMED
Model / Reference
CP641011 EUDAMED
ERM0101001 EUDAMED
CP641000 EUDAMED
ERM0101002 EUDAMED
ERM0101003 EUDAMED
FS-104 EUDAMED
500012 EUDAMED

Identifiers

Primary DI / UDI-DI
06946430423672 EUDAMED
06946430424952 EUDAMED
06946430423733 EUDAMED
06946430419231 EUDAMED
06946430419224 EUDAMED
06946430423740 EUDAMED
06946430419583 EUDAMED
06946430423337 EUDAMED
06946430423443 EUDAMED
06946430421753 EUDAMED
06946430421395 EUDAMED
06946430419514 EUDAMED
06946430422149 EUDAMED
06946430414755 EUDAMED
06946430412898 EUDAMED
06946430423412 EUDAMED
06946430425928 EUDAMED
06946430426055 EUDAMED
06946430426093 EUDAMED
06946430426062 EUDAMED
06946430422880 EUDAMED
06946430426086 EUDAMED
06946430426277 EUDAMED
Basic UDI-DI
694643043606602Q4 EUDAMED
694643043606601Q2 EUDAMED
B-06946430422880 EUDAMED
EMDN Code
R03010199 VENTILATION MASKS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Czechia EUDAMED
Germany EUDAMED
Portugal EUDAMED
Italy EUDAMED
Türkiye EUDAMED
Poland EUDAMED
Belgium EUDAMED
Sweden 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

Resuscitation Mask by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Xiamen Compower Medical Tech. Co., Ltd.
EUDAMED SRN
CN-MF-000011703
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (23)

  • EUDAMED 731e3fbb-dc2b-4a5e-a32b-26cf1e70be67 61 fields · synced Aug 3, 2026
  • EUDAMED 1ab36203-c5a1-4a65-b826-586e4f695a23 61 fields · synced May 11, 2026
  • EUDAMED 3a96b099-a4ca-4dea-a45b-ba0dc86d0d93 61 fields · synced May 17, 2026
  • EUDAMED 6d9c9402-255e-4c44-8480-b579e2108b10 61 fields · synced May 17, 2026
  • EUDAMED afd0cc47-ecfe-4e19-a25b-2645685b59a1 61 fields · synced May 17, 2026
  • EUDAMED 2e7b5bc1-7362-4ddc-89c6-684f6e59a3e9 61 fields · synced May 17, 2026
  • EUDAMED 86585bf3-9c7c-42e5-9ee5-6a2d11a57ae8 61 fields · synced May 17, 2026
  • EUDAMED 4590e9c0-d9ba-4483-bf5c-134ffe872b02 61 fields · synced May 17, 2026
  • EUDAMED 6ddaefb5-3621-4a62-8b85-666d47faa288 61 fields · synced May 17, 2026
  • EUDAMED 87b2083d-75a1-4540-889b-de08f8501d4c 61 fields · synced May 18, 2026
  • EUDAMED b9ded0a2-8881-4bda-bc99-0f64d0c30871 61 fields · synced May 18, 2026
  • EUDAMED 4d830ff0-4329-43f2-a22d-7941cbbd2bcb 61 fields · synced May 18, 2026
  • EUDAMED 7b8a5fb0-f048-42f8-894e-9f88b06a4a69 61 fields · synced May 19, 2026
  • EUDAMED 93777734-e8cc-4015-9bb7-a2965530bf72 61 fields · synced May 19, 2026
  • EUDAMED ae1938f8-4397-4fdf-887d-ae593accabde 61 fields · synced May 19, 2026
  • EUDAMED 21d86abf-a8eb-4b70-83bd-77207d593663 61 fields · synced May 19, 2026
  • EUDAMED d8ed5e14-ffda-4cd6-85f6-6afe87b1e398 61 fields · synced Jul 9, 2026
  • EUDAMED 2624eec4-8ee4-4bc9-b110-18556098c58c 61 fields · synced Jul 9, 2026
  • EUDAMED cff39d90-2af6-44c3-9ad2-0e437c7fd8ae 61 fields · synced Jul 9, 2026
  • EUDAMED c8ae9d7e-a998-48b5-b4b8-b7c014fc269a 61 fields · synced Jul 10, 2026
  • EUDAMED 1055e7c3-5b71-43ab-a0b6-4537e34b1394 61 fields · synced Jul 13, 2026
  • EUDAMED 81cbd28b-62ab-405b-9f6e-6bac89df5d55 61 fields · synced Jul 19, 2026
  • EUDAMED a5476e34-3c2e-4ebb-afee-311a56ba56ac 61 fields · synced Aug 2, 2026