Identity
- Trade Name
- Caries Indicator EUDAMED
- Device Name
- Caries Indicator EUDAMED
- Model / Reference
- LLR-Ⅲ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971752241857 EUDAMED
- Basic UDI-DI
- 697175224LLR-IIIVD EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Caries Indicator by Longly Biotechnology (Wuhan) 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 | 697175224LLR-IIIVD | Class I | Active |
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Manufacturer
- Manufacturer
- Longly Biotechnology (Wuhan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000045632
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED a058aace-0a91-4c3a-b2d8-7573513b3b87 61 fields · synced Oct 7, 2026