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Linear Staplers with Single Use Loading Units
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref RLS3035SModel RLS3035S RLS3048S RLS4535S RLS4548S RLS6035S RLS6048S510(k) K120179Model RLS3035S, RLS3048S, RLS4535S, RLS4548S, RLS6035S, RLS6048S
Identity
- Trade Name
- REACH RLS Staplers EUDAMED
- Device Name
- Linear Staplers with Single Use Loading Units EUDAMED
- Model / Reference
- RLS3035S RLS3048S RLS4535S RLS4548S RLS6035S RLS6048S EUDAMEDRLS3035S EUDAMEDRLS3035S, RLS3048S, RLS4535S, RLS4548S, RLS6035S, RLS6048S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815821039 EUDAMED
- Basic UDI-DI
- B-06953815821039 EUDAMED69538158B41ZS EUDAMED
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Linear Staplers with Single Use Loading Units by Reach Surgical, Inc. — Class IIb — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120179 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-06953815821039 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06953815821039 | 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 (3)
- EUDAMED 284e3652-9cca-4c41-a652-2a4a8fe8cd2b 85 fields · synced Oct 6, 2026
- EUDAMED 61a80d8c-e93b-450b-8f8e-2e32072a7d84 61 fields · synced May 17, 2026
- FDA 510(k) K120179 1 fields · synced May 18, 2026