Identity
- Trade Name
- EN-Dynamic Triceps Dips EUDAMEDFDA UDI
- Generic Name
- Upper-limb mechanical weight exerciser, lever/pulley-cable FDA UDI
- Device Name
- EN-Dynamic EUDAMEDPowered Exercise Equipment FDA UDI
- Model / Reference
- 1455964 EUDAMEDFDA UDI
- Description
- Powered Exercise Equipment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719992508303 EUDAMEDFDA UDI
- Basic UDI-DI
- 871999250814559004Y EUDAMED
- Direct Marketing DI
- 08719992508303 EUDAMED
- FDA Product Code
- BXB FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Upper-limb mechanical weight exerciser, lever/pulley-cable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Market of Registration
- Netherlands 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
No
Incorporates Medicinal Product
No
Prescription Use
Yes
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
Yes
Category: Upper-limb mechanical weight exerciser, lever/pulley-cable
EN-Dynamic Triceps Dips by Enraf-Nonius B.V. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enraf-Nonius B.V.
Sources (2)
- FDA UDI dafa2e64-bd0b-4849-b5d6-d818557913af 34 fields · synced Jul 11, 2026
- EUDAMED 7cdf8c04-f520-4018-9117-bf9fcd204b4c 61 fields · synced Jul 11, 2026