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IREACH MAGNUM PLUS Staplers
EUDAMEDClass IIa (EU MDR)
Ref IMS45LModel IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S.
Identity
- Trade Name
- IREACH MAGNUM PLUS Staplers EUDAMED
- Device Name
- Endoscopic Motorized Cutting Staplers EUDAMED
- Model / Reference
- IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S. EUDAMEDIMS45L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815846988 EUDAMED
- Basic UDI-DI
- 69538158U004E EUDAMED
- EMDN Code
- H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 MAGNUM PLUS 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 | 69538158U004E | 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 (1)
- EUDAMED b02eb7e6-8629-4f4a-94e9-acb06164e703 61 fields · synced Oct 6, 2026