Identity
- Trade Name
- LUNGguard EUDAMED
- Device Name
- SherpaPak Family of Devices EUDAMED
- Model / Reference
- 370 EUDAMED408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20850005470148 EUDAMED10850005470189 EUDAMED
- Basic UDI-DI
- 850005470SHRPF9L EUDAMED
- EMDN Code
- A0999 ORGAN PRESERVATION SOLUTIONS AND CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LUNGguard by Paragonix Technologies, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 850005470SHRPF9L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
- EUDAMED SRN
- US-MF-000038585
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0ac4a922-b40c-482e-9fce-52221e97876c 61 fields · synced Jul 11, 2026
- EUDAMED f85a1cc1-4a43-446a-bf14-3d1bd49fb960 61 fields · synced May 19, 2026