DryShield BMD DS-MPL-005
Ref DS-MPL-005
DryShield BMD DS-MPL-005 is a dental suction system (EU MDD Class IIa; FDA Class I; FDA product code DYN, Mouthpiece, Saliva Ejector) made by Solmetex, LLC, registered in EUDAMED on 6 May 2026 (Basic UDI-DI B-00850045062101) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 00850045062101), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00850045062101 00850045062101 | Date6 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00850045062101 | Date7 Dec 2022 | StatusListed |
Official records
- EUDAMED public site B-00850045062101
- AccessGUDID record 00850045062101
Across registries
- EUDAMED Basic UDI-DI B-00850045062101 registered 6 May 2026 Active
- FDA GUDID UDI-DI 00850045062101 listed 7 Dec 2022 Listed
Timeline
- Listed FDA GUDID 00850045062101
- Registered EUDAMED B-00850045062101
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- DryShield
- Generic name
- Dental suction system
- Device name
- Dryshield Isolation System and Mouthpieces
- Model / reference
- DS-MPL-005 EUDAMEDBMD DS-MPL-005 GUDID
- Primary DI / UDI-DI
- 00850045062101
- Basic UDI-DI
- B-00850045062101
- FDA product code
- DYN
- EMDN code
- Q0199 Odontology devices - other
- GMDN term
- Dental suction system
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 872.6640
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | DS-MPL-005 | BMD DS-MPL-005 |
| Device class | Class IIa | Class I |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 00850045062101: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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