Identity
- Trade Name
- Maxso EUDAMEDFDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- High Speed Air Turbine Handpieces EUDAMEDM200E-M/B2, Non-optic, Single Water Spray FDA UDI
- Model / Reference
- M200E-M/B2 EUDAMEDHP2108 EUDAMEDFDA UDI
- Description
- M200E-M/B2, Non-optic, Single Water Spray FDA UDI
Identifiers
- Catalog Number
- M200E-M/B2 FDA UDI
- Primary DI / UDI-DI
- 00990010302228 EUDAMEDFDA UDI
- Basic UDI-DI
- 990010399818E7 EUDAMED
- Direct Marketing DI
- 00990010302228 EUDAMED
- 510(k) Number
- K101551 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Pneumatic dental handpiece coupler FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Spain 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
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Maxso by Beyes Dental Inc — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 990010399818E7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 990010399818E7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Beyes Dental Inc
- EUDAMED SRN
- CA-MF-000001491
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 5546b98f-ff84-4a51-ac5a-49f4e4455ccc 61 fields · synced Jul 9, 2026
- FDA UDI 4ec97199-66cb-4a91-852f-63a4e7f41af6 35 fields · synced May 25, 2026