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ENDO REACH AFT Reload Units
EUDAMEDClass IIb (EU MDR)
Ref ENDO AFT45BKRModel ENDO AFT45TNR, ENDO AFT45PLR, ENDO AFT45BKR, ENDO AFT60TNR, ENDO AFT60PLR, ENDO AFT60BKR， ENDO AFT45TNBR, ENDO AFT60TNBR, ENDO AFT45PLBR, ENDO AFT60PLBR，
Identity
- Trade Name
- ENDO REACH AFT Reload Units EUDAMED
- Device Name
- Single Use Loading Units for Endoscopic Linear Cutting Staplers EUDAMED
- Model / Reference
- ENDO AFT45TNR, ENDO AFT45PLR, ENDO AFT45BKR, ENDO AFT60TNR, ENDO AFT60PLR, ENDO AFT60BKR， ENDO AFT45TNBR, ENDO AFT60TNBR, ENDO AFT45PLBR, ENDO AFT60PLBR， EUDAMEDENDO AFT45BKR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815842706 EUDAMED
- Basic UDI-DI
- 69538158H442QW EUDAMED
- EMDN Code
- H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER 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 AFT Reload Units 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 | 69538158H442QW | 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 70a0564c-aced-43e3-ac91-2a809fb51434 61 fields · synced Oct 6, 2026