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DIN13164-2022PLUS in a red bag with two colors print, size: 22x13x6cm
EUDAMEDClass I (EU MDR)
Ref /
Identity
- Trade Name
- DIN13164-2022PLUS in a red bag with two colors print, size: 22x13x6cm EUDAMED
- Device Name
- CPR shield EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454783411 EUDAMED
- Basic UDI-DI
- 69514547304V6 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
DIN13164-2022PLUS in a red bag with two colors print, size: 22x13x6cm by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED
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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 | 69514547304V6 | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED fe0c0721-468d-43f1-8c59-76f2ebd9e5fb 61 fields · synced Oct 7, 2026