Identity
- Trade Name
- Allegro Nextgen Reformer™ MTO with Leg Kit EUDAMED
- Device Name
- Reformer-Trapeze Combination (RTC) EUDAMED
- Model / Reference
- 19059C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810052141893 EUDAMED
- Basic UDI-DI
- 0810052148000LS EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Allegro Nextgen Reformer™ MTO with Leg Kit by Balanced Body Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0810052148000LS | Class I | Active |
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Manufacturer
- Manufacturer
- Balanced Body Inc
- EUDAMED SRN
- US-MF-000045340
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED e5aee0e1-c088-4c43-ad83-a8bb4744a586 61 fields · synced Jun 18, 2026