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Lilivis
EUDAMEDFDA UDIClass I (EU MDR)
Ref Y2XXCL-23-00001Model LS-100, LSO-100
Identity
- Trade Name
- Lilivis EUDAMEDLilivis Scan LS-100 FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intra Oral Scanner EUDAMEDLilivis Scan LS-100 (Intraoral Scanner) FDA UDI
- Model / Reference
- LS-100, LSO-100 EUDAMEDY2XXCL-23-00001 EUDAMEDLS-100 FDA UDI
- Description
- Lilivis Scan LS-100 (Intraoral Scanner) FDA UDI
Identifiers
- Catalog Number
- LS-100 FDA UDI
- Primary DI / UDI-DI
- 08800019600893 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196DT001CN EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lilivis by Huvitz Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000196DT001CN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 893f98b2-5ce5-478f-aa6a-15659d7da31a 61 fields · synced Jul 12, 2026
- FDA UDI 94fd0062-bb43-418a-98df-b99bbd1f8fba 35 fields · synced May 30, 2026