Identity
- Trade Name
- HUMAC NORM EUDAMEDFDA UDI
- Generic Name
- Back/leg/chest dynamometer FDA UDI
- Device Name
- HUMAC NORM EUDAMEDHUMAC NORM Extremity System; Dynamometer FDA UDI
- Model / Reference
- 502140 EUDAMEDFDA UDI
- Description
- HUMAC NORM Extremity System; Dynamometer FDA UDI
Identifiers
- Catalog Number
- 502140-00 FDA UDI
- Primary DI / UDI-DI
- 00860139000308 EUDAMEDFDA UDI
- Basic UDI-DI
- 08601390003502140VG EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Back/leg/chest dynamometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Humac Norm by Computer Sports Medicine, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08601390003502140VG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Computer Sports Medicine, Inc.
- EUDAMED SRN
- US-MF-000037948
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 71ae911d-f8a0-4ed1-a12e-3a7f13eb09ee 61 fields · synced Jul 9, 2026
- FDA UDI c2368161-b088-4a11-bf15-f481d1de79d2 36 fields · synced May 29, 2026