PureClarity™
EUDAMEDFDA UDIClass I (EU MDR)
by Parkell Inc.
Identity
- Trade Name
- PureClarity™ EUDAMEDFDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Device Name
- PureClarity Water Filter EUDAMEDPureClarity™ Purification Filter - Installation Kit FDA UDI
- Model / Reference
- D718, D719 EUDAMEDD718 EUDAMEDFDA UDI
- Description
- PureClarity™ Purification Filter - Installation Kit FDA UDI
Identifiers
- Catalog Number
- D718 FDA UDI
- Primary DI / UDI-DI
- 00810000521647 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081000052CLARITYJ4 EUDAMED
- Direct Marketing DI
- 00810000521579 EUDAMED
- FDA Product Code
- JRS FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Microbial water purification filter, non-sterilizable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
PureClarity™ by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081000052CLARITYJ4 | 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 1716a246-f93f-4577-a53b-178943233502 61 fields · synced Jun 18, 2026
- FDA UDI ce138cca-7a5b-4be8-82a4-978c33092388 35 fields · synced May 30, 2026