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SOUND REACH Open Shears
EUDAMEDClass IIb (EU MDR)
Ref SFA9Model SFA9, SFA17Ref SFA17
Identity
- Trade Name
- SOUND REACH Open Shears EUDAMED
- Device Name
- Disposable Ultrasonic Shears EUDAMED
- Model / Reference
- SFA9, SFA17 EUDAMEDSFA9 EUDAMEDSFA17 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815803226 EUDAMED06953815803233 EUDAMED
- Basic UDI-DI
- 69538158BH001KX EUDAMED
- EMDN Code
- K0202010101 ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
SOUND REACH Open Shears by Reach Surgical, Inc. — Class IIb — 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 | 69538158BH001KX | 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 (2)
- EUDAMED 635f7b1e-1b1d-4738-a8ed-bd961b8a0cd3 61 fields · synced Oct 6, 2026
- EUDAMED efb125a9-242e-4192-a41e-4c718c8874ab 61 fields · synced May 17, 2026