Identity
- Trade Name
- IB-LS EUDAMEDInBody FDA UDI
- Generic Name
- Body/limb elastic exerciser FDA UDI
- Device Name
- System, Isokinetic Testing And Evaluation FDA UDI
- Model / Reference
- IB-LS EUDAMEDFDA UDIL2 EUDAMED
- Description
- System, Isokinetic Testing And Evaluation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590945 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959L2YV EUDAMED
- Direct Marketing DI
- 08809209590945 EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Z12062699 DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS – OTHER EUDAMED
- GMDN Term
- Body/limb elastic exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ib-Ls by InBody Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880920959L2YV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- InBody Co., Ltd.
- EUDAMED SRN
- KR-MF-000011833
- Authorised Representative
- InBody Europe B.V. NL-AR-000011789
Sources (2)
- EUDAMED 37e6697f-f4ed-434f-b72c-c5fc74e3f500 61 fields · synced Jul 12, 2026
- FDA UDI 661eda16-5312-4429-b2e2-39aca764195c 35 fields · synced May 30, 2026