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Protective Light Hand Shield
EUDAMEDClass I (EU MDR)
Ref YK03Model FF01,FF04,FF04A,FF05,DE01,FF0102,FF0502,SG01,SG02,SG03,SG04, SG06,SG08,SG08A,SG09,YK03,
Identity
- Trade Name
- Protective Light Hand Shield EUDAMED
- Device Name
- Patient Protective Device EUDAMED
- Model / Reference
- FF01,FF04,FF04A,FF05,DE01,FF0102,FF0502,SG01,SG02,SG03,SG04, SG06,SG08,SG08A,SG09,YK03, EUDAMEDYK03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001134 EUDAMED
- Basic UDI-DI
- 69544540SGFS001US EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Protective Light Hand Shield by Huanghua Promisee Dental 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 | 69544540SGFS001US | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED abd934c2-3022-4f29-9407-0906d409002d 61 fields · synced Oct 6, 2026