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Dental loupes
EUDAMEDClass I (EU MDR)
Ref BR-812Ref BR-811Ref BR-804SRef BR-804BRef BR-804Ref BR-804A
Identity
- Device Name
- Dental loupes EUDAMED
- Model / Reference
- BR-812 EUDAMEDBR-811 EUDAMEDBR-804S EUDAMEDBR-804B EUDAMEDBR-804 EUDAMEDBR-804A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975783736085 EUDAMED06975783736078 EUDAMED06975783736016 EUDAMED06975783736047 EUDAMED06975783736009 EUDAMED06975783736030 EUDAMED
- Basic UDI-DI
- 697578373DL001LH EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Dental loupes by Baru Foshan Medical Technology Co., Limited — 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 | 697578373DL001LH | Class I | Active |
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Manufacturer
- Manufacturer
- Baru Foshan Medical Technology Co., Limited
- EUDAMED SRN
- CN-MF-000045880
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (6)
- EUDAMED 90e86aac-5069-4256-96a3-5fb3e2f8529a 61 fields · synced Oct 6, 2026
- EUDAMED 258c2ea6-a208-48d4-8ef5-b1d7baa35ab5 61 fields · synced May 17, 2026
- EUDAMED 407e3ed0-6650-40a7-9a85-c2e8c658d947 61 fields · synced May 18, 2026
- EUDAMED f6add0cb-daaa-41ec-9b91-ef956bbb68fd 61 fields · synced May 18, 2026
- EUDAMED 662a33fb-a0b7-4502-aade-f790ef7192d4 61 fields · synced May 18, 2026
- EUDAMED 18e4dffb-4c8b-436a-b3a3-c8ec0136a947 61 fields · synced May 18, 2026