Identity
- Trade Name
- Tiger EUDAMED
- Device Name
- Deluxe Bracket Holder with Positioning Blade EUDAMED
- Model / Reference
- OL661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003881610 EUDAMED
- Basic UDI-DI
- 8964004046OL66158 EUDAMED
- Direct Marketing DI
- 08964003881610 EUDAMED
- EMDN Code
- L15901199 POSITIONING INSTRUMENTS FOR DENTAL DEVICES, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Tiger by Lead Dental Instruments Co. — 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 | 8964004046OL66158 | Class I | Active |
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Manufacturer
- Manufacturer
- Lead Dental Instruments Co.
- EUDAMED SRN
- PK-MF-000029995
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 2771bae5-fed1-491c-883e-09e660f3417b 61 fields · synced Jun 19, 2026