Identity
- Trade Name
- Guided Sleeves EUDAMED
- Device Name
- Fixation Pin Guide Sleeve EUDAMED
- Model / Reference
- Guided Sleeves EUDAMEDDGS-SL600-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290109284576 EUDAMED
- Basic UDI-DI
- 729010928SLELB EUDAMED
- Direct Marketing DI
- 07290109284576 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - 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
Guided Sleeves by Ditron Dental 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 | 729010928SLELB | Class I | Active |
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Manufacturer
- Manufacturer
- Ditron Dental Ltd.
- EUDAMED SRN
- IL-MF-000015966
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED 5a738204-68ee-49cd-a2c8-57138163f85e 61 fields · synced Jul 21, 2026