Identity
- Trade Name
- Plaque Indicator EUDAMED
- Device Name
- Plaque Indicator EUDAMED
- Model / Reference
- LLR-Ⅱ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971752241901 EUDAMED
- Basic UDI-DI
- 697175224LLR-IIMP 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
Plaque 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-IIMP | 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 8568c526-ba9c-4382-b798-e74e3d52ad95 61 fields · synced Oct 6, 2026