Identity
- Trade Name
- BARRIER SLEEVES EUDAMED
- Device Name
- BARRIER SLEEVES EUDAMED
- Model / Reference
- headrest covers EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975652002563 EUDAMED06975652002549 EUDAMED
- Basic UDI-DI
- 697565200BS001CR EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMEDGermany 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 — CE/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 (2)
- EUDAMED c5ab29b7-a669-4749-a4db-3f02322f8d6b 61 fields · synced Oct 6, 2026
- EUDAMED b0d6f68a-63d0-451c-979a-b35ebc6a15bd 61 fields · synced May 19, 2026