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PGDx elio tissue complete
EUDAMEDFDA 510(k)Class C (EU MDR)
Ref A0220100Ref B01102200
Identity
- Trade Name
- PGDx elio tissue complete EUDAMED
- Device Name
- PGDx elio tissue complete EUDAMED
- Model / Reference
- A0220100 EUDAMEDB01102200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00192721001487 EUDAMED00192721001470 EUDAMED
- Basic UDI-DI
- 0192721U0200100NL EUDAMED
- Direct Marketing DI
- 00192721001487 EUDAMED00192721001470 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
PGDx elio tissue complete by Personal Genome Diagnostics, Inc. — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192063 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 0192721U0200100NL | Class C | Active |
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Manufacturer
- Manufacturer
- Personal Genome Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000026862
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED fcdf09e3-7e75-4fba-9dfb-94c6405117fc 61 fields · synced Aug 4, 2026
- EUDAMED 791a67c2-8eed-47c5-9746-37751f2cc213 61 fields · synced May 18, 2026
- FDA 510(k) K192063 1 fields · synced May 18, 2026