Identity
- Trade Name
- IB-HGSm EUDAMEDInBody FDA UDI
- Generic Name
- Hand dynamometer/pinchmeter, electronic FDA UDI
- Device Name
- InGrip(Handgrip Strength Dynamometer) EUDAMEDThis is a Handheld Dynamometer FDA UDI
- Model / Reference
- IB-HGSm EUDAMEDU7 EUDAMEDInGrip(IB-HGSm) FDA UDI
- Description
- This is a Handheld Dynamometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209591980 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959U725 EUDAMED
- Direct Marketing DI
- 08809209591980 EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Z12062699 DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS – OTHER EUDAMED
- GMDN Term
- Hand dynamometer/pinchmeter, electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- 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
Yes
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-HGSm 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 | 880920959U725 | 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 29649380-a133-40c9-9aa1-d123f87c04ce 61 fields · synced Jul 30, 2026
- FDA UDI b7af201d-73dd-4147-8625-06e1d033f066 33 fields · synced May 30, 2026