Identity
- Trade Name
- Parkell® EUDAMEDFDA UDI
- Generic Name
- Particulate water purification filter FDA UDI
- Device Name
- Water Filter EUDAMEDReplacement Water Filter Disks (Pkg. of 10 Disks) for all Scalers & Irrigators FDA UDI
- Model / Reference
- D419 EUDAMEDD410 FDA UDI
- Description
- Replacement Water Filter Disks (Pkg. of 10 Disks) for all Scalers & Irrigators FDA UDI
Identifiers
- Catalog Number
- D419 FDA UDI
- Primary DI / UDI-DI
- 10810000522054 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052WATERFILTERC7 EUDAMED
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Z12119080 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Particulate water purification filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 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
No
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 | 081000052WATERFILTERC7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED 505461dd-1c90-412f-8554-0d6f33d91139 61 fields · synced Jun 6, 2026
- FDA UDI ad7c002b-2f99-4753-b989-5909c4cfee1a 35 fields · synced May 30, 2026