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Fluorinated foam
EUDAMEDClass I (EU MDR)
Ref 08Model orangeModel grapeModel cantaloupeModel appleModel strawberry
Identity
- Trade Name
- Fluorinated foam EUDAMED
- Device Name
- Fluoride foam EUDAMED
- Model / Reference
- orange EUDAMED08 EUDAMEDgrape EUDAMEDcantaloupe EUDAMEDapple EUDAMEDstrawberry EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974998830779 EUDAMED06974998830564 EUDAMED06974998830953 EUDAMED06974998830274 EUDAMED06974998830656 EUDAMED06974998831035 EUDAMED06974998830762 EUDAMED06974998830960 EUDAMED06974998830687 EUDAMED06974998830786 EUDAMED06974998830939 EUDAMED06974998830878 EUDAMED06974998830342 EUDAMED06974998830748 EUDAMED06974998830083 EUDAMED06974998830069 EUDAMED06974998830137 EUDAMED06974998830755 EUDAMED06974998830359 EUDAMED06974998830700 EUDAMED06974998831028 EUDAMED06974998830854 EUDAMED06974998830052 EUDAMED06974998830090 EUDAMED06974998830335 EUDAMED06974998830175 EUDAMED06974998830496 EUDAMED06974998830229 EUDAMED06974998830922 EUDAMED06974998830113 EUDAMED06974998830533 EUDAMED06974998830977 EUDAMED06974998830168 EUDAMED06974998830861 EUDAMED06974998830731 EUDAMED06974998830526 EUDAMED06974998830724 EUDAMED06974998830120 EUDAMED06974998830144 EUDAMED06974998830489 EUDAMED06974998830366 EUDAMED06974998830588 EUDAMED06974998830502 EUDAMED06974998830670 EUDAMED06974998830410 EUDAMED06974998830106 EUDAMED06974998830816 EUDAMED
- Basic UDI-DI
- 6974998830804MF EUDAMED6974998830803MD EUDAMED6974998830802MB EUDAMED6974998830805MH EUDAMED6974998830801M9 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Fluorinated foam by Chengdu I-ReHealth Medical Devices Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6974998830804MF | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu I-ReHealth Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000019445
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (47)
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