Identity
- Device Name
- Oral observer EUDAMED
- Model / Reference
- universal EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978192320005 EUDAMED
- Basic UDI-DI
- 697819232OralobserverB5 EUDAMED
- EMDN Code
- Z119003 BIOIMAGING PHOTOGRAPHY INSTRUMENTS 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
Oral observer by BLTY (Hangzhou) Medical Technology 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 | 697819232OralobserverB5 | Class I | Active |
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Manufacturer
- Manufacturer
- BLTY (Hangzhou) Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045026
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d5f06040-a40a-444d-b8c6-ba919b271e78 61 fields · synced Jul 30, 2026