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ENDO REACH REC Reloads
EUDAMEDClass IIb (EU MDR)
Ref REC60GRAModel REC45GRA, REC45WHT, REC45BLU, REC45GLD, REC60GRA, REC60WHT, REC60BLU, REC60GLD, IMST60TAN, IMST60PUL, IMST45TAN, IMST45PUL.
Identity
- Trade Name
- ENDO REACH REC Reloads EUDAMED
- Device Name
- Single Use Loading Units for Endoscopic Linear Cutting Staplers EUDAMED
- Model / Reference
- REC45GRA, REC45WHT, REC45BLU, REC45GLD, REC60GRA, REC60WHT, REC60BLU, REC60GLD, IMST60TAN, IMST60PUL, IMST45TAN, IMST45PUL. EUDAMEDREC60GRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815843314 EUDAMED
- Basic UDI-DI
- 69538158P634D EUDAMED
- EMDN Code
- H02030106 LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY 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
ENDO REACH REC Reloads by Reach Surgical, Inc. — Class IIb — 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 | 69538158P634D | 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 (1)
- EUDAMED 58d6ff3a-2d1d-43be-974a-d84bd9023ab8 61 fields · synced Jun 19, 2026