Identity
- Trade Name
- MAXSO EUDAMEDFDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- X200X-M/N EUDAMEDX200X-M/N,NSK Backend, Quattro Spray, IS Technology, Fiber Optic (NEW) FDA UDI
- Model / Reference
- HP2066X EUDAMEDFDA UDI
- Description
- X200X-M/N,NSK Backend, Quattro Spray, IS Technology, Fiber Optic (NEW) FDA UDI
Identifiers
- Catalog Number
- X200X-M/N FDA UDI
- Primary DI / UDI-DI
- 00990010301443 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00990010301443 EUDAMED
- 510(k) Number
- K101551 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00990010301443 | 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 0de9dac5-c851-4b68-a315-a07c01736525 61 fields · synced Jul 11, 2026
- FDA UDI e1e21c0b-9d92-4e33-bb4a-122944c10dd0 35 fields · synced May 30, 2026