Identity
- Trade Name
- Tiger EUDAMED
- Device Name
- Direct Bond Bracket Holder EUDAMED
- Model / Reference
- OL405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003881016 EUDAMED
- Basic UDI-DI
- 8964004046OL4054L EUDAMED
- Direct Marketing DI
- 08964003881016 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS 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
Category: Orthodontic tube
Tiger by Lead Dental Instruments Co. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8964004046OL4054L | 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 0531aadb-2a92-424e-8153-37fc1cddf639 61 fields · synced Jun 19, 2026