Identity
- Trade Name
- Cotton Roll Holder EUDAMEDFDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- Cotton Roll Holder EUDAMED
- Model / Reference
- 5405 EUDAMED5405/4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29954050 EUDAMED+E2995405/40 EUDAMEDE299540540 FDA UDI
- Basic UDI-DI
- ++E299COTTONROLLHOLDERNU EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental cotton roll FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cotton Roll Holder by Polydentia SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E299COTTONROLLHOLDERNU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (3)
- EUDAMED 6f96bfa1-d65e-4a12-bf54-b0d3a26f520c 61 fields · synced Jul 17, 2026
- EUDAMED ec215695-7817-4be9-9983-c49d29a8b5f2 61 fields · synced May 19, 2026
- FDA UDI 25e7c685-a1ee-4e91-b695-2d6fc880e4e2 33 fields · synced May 30, 2026