Identity
- Trade Name
- EN-Dynamic Abdominal Trainer EUDAMEDFDA UDI
- Generic Name
- Core-body mechanical weight exerciser FDA UDI
- Device Name
- EN-Dynamic EUDAMEDPowered Exercise Equipment FDA UDI
- Model / Reference
- 1455954 EUDAMEDFDA UDI
- Description
- Powered Exercise Equipment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719992508204 EUDAMEDFDA UDI
- Basic UDI-DI
- 871999250814559004Y EUDAMED
- Direct Marketing DI
- 08719992508204 EUDAMED
- FDA Product Code
- BXB FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Core-body mechanical weight exerciser 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
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
Yes
FDA UDI
Over-the-Counter
No
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
Category: Core-body mechanical weight exerciser
EN-Dynamic Abdominal Trainer by Enraf-Nonius B.V. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Core-body mechanical weight exerciser.
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- MedX — MEDX HOLDINGS, INC. · Class II
- EN-Dynamic Back Trainer — Enraf-Nonius B.V. · Class I
- EN-Dynamic Rotator — Enraf-Nonius B.V. · Class I
- EN-Dynamic Fly — Enraf-Nonius B.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 4dd65fc1-5778-4634-a90e-1fa6abee4070 34 fields · synced Jul 9, 2026
- EUDAMED 6a7e974e-fd3d-4b1c-b9b1-4bf612362426 61 fields · synced Jul 9, 2026