Identity
- Trade Name
- DryDent EUDAMEDFDA UDI
- Generic Name
- Saliva absorbent FDA UDI
- Device Name
- Saliva absorbent EUDAMED
- Model / Reference
- 416069 EUDAMEDSublingual S FDA UDI
Identifiers
- Catalog Number
- 416069 FDA UDI
- Primary DI / UDI-DI
- 17310234160693 EUDAMEDFDA UDI
- Basic UDI-DI
- 731023999520AQ EUDAMED
- Unit of Use DI
- 17310231057804 EUDAMED
- FDA Product Code
- KHR FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Saliva absorbent FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6050 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
DryDent by Directa AB — 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 | 731023999520AQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Directa AB
- EUDAMED SRN
- SE-MF-000002500
Sources (2)
- EUDAMED 191dfdaf-2bb5-4970-9839-c7f3e0e155a5 61 fields · synced Jun 8, 2026
- FDA UDI 24a04756-5cef-4d6b-a882-43e41f30b80e 33 fields · synced May 30, 2026