Identity
- Trade Name
- BAROguard EUDAMED
- Device Name
- SherpaPak Family of Devices EUDAMED
- Model / Reference
- 10653 EUDAMED373 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850005470233 EUDAMED20850005470315 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
Yes
EUDAMEDEUDAMED
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
BAROguard by Paragonix Technologies, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223874 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 850005470SHRPF9L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
- EUDAMED SRN
- US-MF-000038585
- FDA Applicant
- Paragonix Technologies
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED bfcd0c67-ff0f-4f87-8269-4892a27d80be 85 fields · synced Aug 2, 2026
- EUDAMED 8171ce38-ebf0-4682-8556-ed6029136379 61 fields · synced Aug 2, 2026
- FDA 510(k) K223874 1 fields · synced May 18, 2026