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Surgical Guide Resin
EUDAMEDClass I (EU MDR)
Ref DB-07Model DB-07 or Customized
Identity
- Device Name
- Surgical Guide Resin EUDAMED
- Model / Reference
- DB-07 or Customized EUDAMEDDB-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976693450016 EUDAMED
- Basic UDI-DI
- 697669345DB07P9 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS 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
Category: Dental appliance fabrication material, resin
Surgical Guide Resin by Shenzhen Yongchanghe Technology CO. , Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697669345DB07P9 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yongchanghe Technology CO. , Ltd.
- EUDAMED SRN
- CN-MF-000037344
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e3e8c7f8-0831-4644-b31a-0405868808ca 61 fields · synced Oct 6, 2026