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IREACH OMNIA Staplers
EUDAMEDClass IIa (EU MDR)
Ref IDS-0Model IDL-0, IDM-0, IDS-0Ref IDLModel IDL, IDM, IDSRef IDMRef IDS
Identity
- Trade Name
- IREACH OMNIA Staplers EUDAMED
- Device Name
- Powered Articulating Staplers EUDAMED
- Model / Reference
- IDL-0, IDM-0, IDS-0 EUDAMEDIDS-0 EUDAMEDIDL, IDM, IDS EUDAMEDIDL EUDAMEDIDM EUDAMEDIDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815847299 EUDAMED06953815846254 EUDAMED06953815846261 EUDAMED06953815846278 EUDAMED
- Basic UDI-DI
- 69538158W4156 EUDAMED69538158W014S EUDAMED
- EMDN Code
- H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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
IREACH OMNIA Staplers by Reach Surgical, Inc. — Class IIa — 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 | 69538158W4156 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Reach Surgical, Inc.
- EUDAMED SRN
- CN-MF-000011148
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED e31637f7-6862-4789-b92f-d2766b76d0aa 61 fields · synced Oct 6, 2026
- EUDAMED a4564a5f-820a-4e0c-b966-0cdc4877c074 61 fields · synced May 17, 2026
- EUDAMED e643f81e-7663-4b57-99b8-517656ab0633 61 fields · synced May 18, 2026
- EUDAMED e692da02-ad5b-42dd-b02a-2dde0ef1622d 61 fields · synced May 19, 2026