Identity
- Trade Name
- Water Units EUDAMEDWater Unit FDA UDI
- Generic Name
- Dental cuspidor FDA UDI
- Device Name
- Water Units EUDAMEDWater Unit Syncrus G2 FDA UDI
- Model / Reference
- SYNCRUS G2 EUDAMEDFDA UDI41000008184 EUDAMED
- Description
- Water Unit Syncrus G2 FDA UDI
Identifiers
- Catalog Number
- 41000008184 FDA UDI
- Primary DI / UDI-DI
- 07899581343933 EUDAMEDFDA UDI
- Basic UDI-DI
- 78995813WaterUnit004X3 EUDAMED
- 510(k) Number
- K964619 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- V080280 MEDICAL CHAIRS - ACCESSORIES EUDAMED
- GMDN Term
- Dental cuspidor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Water Units by Alliage S/A Indústrias Médico Odontológica — 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 | 78995813WaterUnit004X3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alliage S/A Indústrias Médico Odontológica
- EUDAMED SRN
- BR-MF-000016681
- Authorised Representative
- ELS SOLUTIONS GDIA - UNIPESSOAL LDA. PT-AR-000026128
Sources (2)
- EUDAMED 7124ee02-c1a1-4737-9824-a4c61812bd90 61 fields · synced Oct 7, 2026
- FDA UDI 5e869ab6-a19e-49e0-9921-40a6b7b2fbc0 35 fields · synced May 30, 2026