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Dental Sleeves
EUDAMEDClass I (EU MDR)
Ref DS09CModel DS01A,DS01B,DS02A,DS02B,DS03A,DS04A,DS05A,DS09B
Identity
- Trade Name
- Dental Sleeves EUDAMED
- Device Name
- Dental Sleeves EUDAMED
- Model / Reference
- DS01A,DS01B,DS02A,DS02B,DS03A,DS04A,DS05A,DS09B EUDAMEDDS09C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454012277 EUDAMED
- Basic UDI-DI
- 69544540DESL001NX EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Dental Sleeves by Huanghua Promisee Dental 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 | 69544540DESL001NX | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 0e7fa04d-b2cf-42b7-8287-7d1cdc005eb2 61 fields · synced Jun 18, 2026