Identity
- Trade Name
- LIPOcel EUDAMED
- Model / Reference
- LIPOcel EUDAMED11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800020100153 EUDAMED
- Basic UDI-DI
- B-08800020100153 EUDAMED
- EMDN Code
- Z11049099 VARIOUS ULTRASOUND INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
LIPOcel by Jeisys Medical Inc. — Class IIb — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181896 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08800020100153 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- EUDAMED SRN
- KR-MF-000008513
- FDA Applicant
- Jeisys Medical, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 99e8744b-1456-4d5c-a7f8-e68df236cd46 85 fields · synced Jun 18, 2026
- FDA 510(k) K181896 1 fields · synced May 18, 2026