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ENER REACH SR Footswitch
EUDAMEDClass IIb (EU MDR)
Ref OP-FSDModel OP9, Accessories: OP-BPC，OP-FSD，OP-FSS，USC
Identity
- Trade Name
- ENER REACH SR Footswitch EUDAMED
- Device Name
- Electrosurgical Instruments, Accessories: Electrosurgery Bipolar Converter,Ultrasonic Footswitch,Electrosurgical Footswitch, Ultrasonic Converter, EUDAMED
- Model / Reference
- OP9, Accessories: OP-BPC，OP-FSD，OP-FSS，USC EUDAMEDOP-FSD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815803028 EUDAMED
- Basic UDI-DI
- 69538158Y101TQ EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Foot-switch, electrical
ENER REACH SR Footswitch by Reach Surgical, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69538158Y101TQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Reach Surgical, Inc.
- EUDAMED SRN
- CN-MF-000011148
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4ecdb53e-524c-4cf7-a564-c83bc41dbfe1 61 fields · synced Jul 9, 2026