Identity
- Trade Name
- BARRIER SLEEVES EUDAMED
- Device Name
- BARRIER SLEEVES EUDAMED
- Model / Reference
- X-Ray Sensor Cover EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978502823288 EUDAMED06975652002860 EUDAMED06975652007919 EUDAMED06975652003089 EUDAMED06975652002877 EUDAMED06978502823325 EUDAMED06975652003195 EUDAMED06978502823332 EUDAMED06978502823240 EUDAMED06978502823264 EUDAMED06978502823349 EUDAMED06975652003171 EUDAMED
- Basic UDI-DI
- 697565200BS001CR 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
Barrier Sleeves by Hubei Guarddent Medical Technology 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 | 697565200BS001CR | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (12)
- EUDAMED 1b2295f2-0e63-4a21-a86f-8d25289583c2 61 fields · synced Oct 6, 2026
- EUDAMED 868c2aa5-b9e7-4765-aff7-41f3a61a6316 61 fields · synced May 17, 2026
- EUDAMED 20b2eeb1-e9e3-48cb-9b86-71c1124af882 61 fields · synced May 17, 2026
- EUDAMED 9f2a96a0-710d-4d65-8497-e35cbc0f6441 61 fields · synced May 17, 2026
- EUDAMED bb4881ed-8bc6-4415-8429-aef3ca5741a0 61 fields · synced May 17, 2026
- EUDAMED 14e98f20-31ea-4657-88db-aab5d7e8f317 61 fields · synced May 17, 2026
- EUDAMED 747cb43a-c3f9-4200-84f5-1847befc52e4 61 fields · synced May 18, 2026
- EUDAMED 44607dd1-e3a7-4a54-aa4d-79d4c34585c4 61 fields · synced May 18, 2026
- EUDAMED c3fd33c5-b2f3-4773-92a5-1542f060444a 61 fields · synced May 19, 2026
- EUDAMED b7fbd3f4-cb47-4eec-9e8d-5971c5b9351d 61 fields · synced May 19, 2026
- EUDAMED d5ca02a6-e008-433a-8bdf-c815b95da605 61 fields · synced May 19, 2026
- EUDAMED 5fb46453-f3a6-4b52-b208-94a2bdc20dd3 61 fields · synced May 19, 2026