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PureClarity™
EUDAMEDFDA UDIClass I (EU MDR)
Ref D719Model D718, D719
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™ Waterline Purification Filter FDA UDI
- Model / Reference
- D718, D719 EUDAMEDD719 EUDAMEDFDA UDI
- Description
- PureClarity™ Waterline Purification Filter FDA UDI
Identifiers
- Catalog Number
- D719 FDA UDI
- Primary DI / UDI-DI
- 00810000521579 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
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
PureClarity™ 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 | 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 02952a00-327c-419b-a783-f7011abb6bb0 61 fields · synced Sep 18, 2026
- FDA UDI 01039551-ed71-412e-a0b8-4d4689ed6ce5 35 fields · synced May 29, 2026