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SOUND REACH SR7 Shears
EUDAMEDClass IIb (EU MDR)
Ref SRB23Model SRB14, SRB23, SRB36, SRB45, SRE14, SRE23, SRE36, SRE45Ref SRE23Ref SRE14Ref SRB45Ref SRE36Ref SRE45Ref SRB14
Identity
- Trade Name
- SOUND REACH SR7 Shears EUDAMED
- Device Name
- Disposable Ultrasonic Shears EUDAMED
- Model / Reference
- SRB14, SRB23, SRB36, SRB45, SRE14, SRE23, SRE36, SRE45 EUDAMEDSRB23 EUDAMEDSRE23 EUDAMEDSRE14 EUDAMEDSRB45 EUDAMEDSRE36 EUDAMEDSRE45 EUDAMEDSRB14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815802601 EUDAMED06953815802526 EUDAMED06953815802519 EUDAMED06953815802625 EUDAMED06953815802533 EUDAMED06953815802540 EUDAMED06953815802595 EUDAMED
- Basic UDI-DI
- 69538158F147QB EUDAMED
- EMDN Code
- K0202010102 LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC 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 SR7 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 | 69538158F147QB | 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 (7)
- EUDAMED ec01c9e0-a1af-4ff1-914d-2ed4d9735897 61 fields · synced Oct 6, 2026
- EUDAMED abfb9bf8-b978-401a-ab04-d072671ae415 61 fields · synced May 17, 2026
- EUDAMED 50252561-5659-44e9-b3fb-15d00d6a3934 61 fields · synced May 17, 2026
- EUDAMED 7cdb6cc7-a875-40a4-b15d-51973251d18a 61 fields · synced May 17, 2026
- EUDAMED 1ef3c89a-3d9c-4f9b-81cd-693cf62a9071 61 fields · synced May 18, 2026
- EUDAMED a5d0d1f3-159c-47a2-97ea-7a9049ede1c2 61 fields · synced May 18, 2026
- EUDAMED 3875a289-3882-4c94-8db9-54d394a00527 61 fields · synced May 19, 2026