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Elong™
EUDAMEDClass III (EU MDR)
Ref 60172306Ref 60192404Ref 60192405Ref 60322301Ref 60172304Ref 60262801
Identity
- Trade Name
- Elong™ EUDAMED
- Device Name
- Elong™ Microcatheter EUDAMED
- Model / Reference
- 60172306 EUDAMED60192404 EUDAMED60192405 EUDAMED60322301 EUDAMED60172304 EUDAMED60262801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949450480915 EUDAMED06949450480960 EUDAMED06949450480977 EUDAMED06949450481530 EUDAMED06949450480892 EUDAMED06949450481318 EUDAMED
- Basic UDI-DI
- B-06949450480915 EUDAMEDB-06949450480960 EUDAMEDB-06949450480977 EUDAMEDB-06949450481530 EUDAMEDB-06949450480892 EUDAMEDB-06949450481318 EUDAMED
- EMDN Code
- C0104010202 CARDIAC ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elong™ by APT Medical Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06949450480915 | Class III | Active |
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Manufacturer
- Manufacturer
- APT Medical Inc.
- EUDAMED SRN
- CN-MF-000009046
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED a0d24b70-f7a7-4df8-84ec-79827a0bf147 61 fields · synced Jul 27, 2026
- EUDAMED cb0a5dad-1cd5-424e-9992-1967f5282302 61 fields · synced May 17, 2026
- EUDAMED 07073975-0272-4efd-9f1c-c4b794ef8eb5 61 fields · synced May 17, 2026
- EUDAMED b0a4b8ad-1594-42d2-b7bd-e708c7cb2180 61 fields · synced May 18, 2026
- EUDAMED f555d3f7-a233-4107-a842-52319a81c56d 61 fields · synced May 18, 2026
- EUDAMED 1740bab4-c754-4142-bf60-eb798a3e4730 61 fields · synced May 19, 2026