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IREACH MAGNUM Staplers
EUDAMEDClass IIa (EU MDR)
Ref IM45AM-0Model IMS60L-0Ref IM60ASModel IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S.Ref IM60AM
Identity
- Trade Name
- IREACH MAGNUM Staplers EUDAMEDIREACH MAGNUM Staplers EUDAMED
- Device Name
- Endoscopic Motorized Cutting Staplers EUDAMED
- Model / Reference
- IMS60L-0 EUDAMEDIM45AM-0 EUDAMEDIM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S. EUDAMEDIM60AS EUDAMEDIM60AM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815847268 EUDAMED06953815844724 EUDAMED06953815844748 EUDAMED
- Basic UDI-DI
- 69538158V114Q EUDAMED69538158U004E 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 MAGNUM 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 | 69538158V114Q | 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 (3)
- EUDAMED fed0f7a0-4588-46e1-a419-431349b46a25 61 fields · synced Oct 6, 2026
- EUDAMED 61d2bb27-c136-49a9-8c3a-9679c33013de 61 fields · synced May 16, 2026
- EUDAMED dc176cbb-24e0-479d-b8cf-df9f0005a722 61 fields · synced May 18, 2026