Identity
- Trade Name
- Parkell® EUDAMEDFDA UDI
- Generic Name
- Dental material mixing surface, chairside, reusable FDA UDI
- Device Name
- Mixing Well EUDAMEDWhite 2-Cavity Mixing Wells (2-pcs) FDA UDI
- Model / Reference
- S373 EUDAMEDFDA UDI
- Description
- White 2-Cavity Mixing Wells (2-pcs) FDA UDI
Identifiers
- Catalog Number
- S373 FDA UDI
- Primary DI / UDI-DI
- 10810000529657 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052MIXINGWELLL6 EUDAMED
- Unit of Use DI
- 00810000529650 EUDAMED
- FDA Product Code
- KLE FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material mixing surface, chairside, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Parkell® by Parkell, Inc. — 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 | 081000052MIXINGWELLL6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED ad44c601-521d-4c01-a3a3-d7ae5f772ff1 61 fields · synced May 31, 2026
- FDA UDI 32de5824-aa91-4a9f-b3bf-8869815fbd28 35 fields · synced May 29, 2026