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IREACH MAGNUM Staplers
EUDAMEDClass IIa (EU MDR)
Ref IM45ASModel IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S.Ref IM60AS-0Model IMS60L-0Ref IM45AL-0Ref IM60AL-0Ref IM60AM-0Ref IM45AS-0Ref IM45AM
Identity
- Trade Name
- IREACH MAGNUM Staplers EUDAMEDIREACH MAGNUM Staplers EUDAMED
- Device Name
- Endoscopic Motorized Cutting Staplers EUDAMED
- Model / Reference
- IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S. EUDAMEDIM45AS EUDAMEDIMS60L-0 EUDAMEDIM60AS-0 EUDAMEDIM45AL-0 EUDAMEDIM60AL-0 EUDAMEDIM60AM-0 EUDAMEDIM45AS-0 EUDAMEDIM45AM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815844731 EUDAMED06953815847237 EUDAMED06953815847220 EUDAMED06953815847213 EUDAMED06953815847251 EUDAMED06953815847244 EUDAMED06953815844755 EUDAMED
- Basic UDI-DI
- 69538158U004E EUDAMED69538158V114Q EUDAMED
- EMDN Code
- H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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 | 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 (7)
- EUDAMED da1a7826-317e-467f-a9ad-cedaea3a4cfc 61 fields · synced Oct 6, 2026
- EUDAMED 6892bfed-55d6-49ec-9e5d-081254b22c30 61 fields · synced May 16, 2026
- EUDAMED 2437947b-52e1-48f9-aef0-7efe3bd05cc5 61 fields · synced May 17, 2026
- EUDAMED d33aa389-d9d3-4504-86b0-12a748f5c1de 61 fields · synced May 17, 2026
- EUDAMED cacd7e34-e825-4225-a765-719dc7b48e97 61 fields · synced May 18, 2026
- EUDAMED 7eff6a91-9702-464d-988f-5e1e376e4780 61 fields · synced May 18, 2026
- EUDAMED 54513e96-caaf-4ccd-a775-fb22b0b21177 61 fields · synced May 19, 2026