← Back to catalogue
Safety Glasses
EUDAMEDClass I (EU MDR)
Ref SG08Model FF01,FF04,FF04A,FF05,DE01,FF0102,FF0502,SG01,SG02,SG03,SG04, SG06,SG08,SG08A,SG09,YK03,
Identity
- Trade Name
- Safety Glasses 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, EUDAMEDSG08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454002063 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
Safety Glasses 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED c5175999-5f80-49b0-be5a-4a22b693e17e 61 fields · synced Oct 7, 2026