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Heart Hugger
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref GT-1000 REGModel Heart Hugger Sternum Support HarnessRef GT1500-LargeRef GT2000-XLRef GT500-Small
Identity
- Trade Name
- Heart Hugger EUDAMED
- Device Name
- Heart Hugger Sternum Support Harness EUDAMED
- Model / Reference
- Heart Hugger Sternum Support Harness EUDAMEDGT-1000 REG EUDAMEDGT1500-Large EUDAMEDGT2000-XL EUDAMEDGT500-Small EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00867839000416 EUDAMED00867839000423 EUDAMED00867839000430 EUDAMED00867839000409 EUDAMED
- Basic UDI-DI
- 08678390004HH001V4 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heart Hugger by General Cardiac Technology, Inc. — Class I — 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 | K882592 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08678390004HH001V4 | Class I | Active |
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Manufacturer
- Manufacturer
- General Cardiac Technology, Inc.
- EUDAMED SRN
- US-MF-000033435
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (5)
- EUDAMED 884f47b1-cac5-4689-91ac-aced90c448a1 61 fields · synced Aug 2, 2026
- EUDAMED 7084c990-8adc-41cc-95b8-1e6930da43cf 61 fields · synced May 17, 2026
- EUDAMED e7401eab-dd0f-4693-9462-4c644f30c762 61 fields · synced May 17, 2026
- EUDAMED 30d001bf-e590-4685-81aa-e98dcea40fd8 61 fields · synced May 18, 2026
- FDA 510(k) K882592 1 fields · synced May 18, 2026