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Dental cotton roll
EUDAMEDClass I (EU MDR)
Ref HN1035Model HN1035；HN1036；HN1037；HN1038
Identity
- Device Name
- Dental cotton roll EUDAMED
- Model / Reference
- HN1035；HN1036；HN1037；HN1038 EUDAMEDHN1035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973454362007 EUDAMED
- Basic UDI-DI
- 697345436HNDCR01UD EUDAMED
- EMDN Code
- Q019004 DENTAL COTTON ROLLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental cotton roll by Shanghai Hua En Industrial 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 | 697345436HNDCR01UD | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Hua En Industrial Co Ltd
- EUDAMED SRN
- CN-MF-000008902
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 29cc48e5-d40c-4492-adf0-4b01c33a055b 61 fields · synced Jun 18, 2026