Identity
- Trade Name
- Mini-StemTM System EUDAMED
- Device Name
- Mini‐Stem System - Adipose Harvesting and Processing System EUDAMED
- Model / Reference
- JTL-250-01-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860003545201 EUDAMED
- Basic UDI-DI
- 00860003545201TD01VN EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: General-purpose suction system, pneumatic
Mini-StemTM System by Jointechlabs, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K182732 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 00860003545201TD01VN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jointechlabs, Inc.
- EUDAMED SRN
- US-MF-000044356
- Authorised Representative
- Eywa srl IT-AR-000033274
Sources (2)
- EUDAMED 735e8c18-d6a9-45e7-ba2d-5a60e501129d 61 fields · synced Jul 16, 2026
- FDA 510(k) K182732 1 fields · synced May 18, 2026