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ENDO REACH REC Staplers
EUDAMEDClass IIa (EU MDR)
Ref REC45BAModel REC60A, REC45A, REC60AL, REC45AL, REC60AS, REC45AS; REC60BA, REC45BA, REC60BAL, REC45BAL, REC60BAS, REC45BAS
Identity
- Trade Name
- ENDO REACH REC Staplers EUDAMED
- Device Name
- Endoscopic Linear Cutting Staplers EUDAMED
- Model / Reference
- REC60A, REC45A, REC60AL, REC45AL, REC60AS, REC45AS; REC60BA, REC45BA, REC60BAL, REC45BAL, REC60BAS, REC45BAS EUDAMEDREC45BA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815843147 EUDAMED
- Basic UDI-DI
- 69538158P003M EUDAMED
- EMDN Code
- H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
ENDO REACH REC 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 | 69538158P003M | 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 3923cf2b-b4d9-49f7-921a-af2ac1f0b5fe 61 fields · synced Jun 18, 2026