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ENDO REACH AFT Reload Units
EUDAMEDClass IIb (EU MDR)
Ref ENDO AFT60BKRModel ENDO AFT45TNR, ENDO AFT45PLR, ENDO AFT45BKR, ENDO AFT60TNR, ENDO AFT60PLR, ENDO AFT60BKR， ENDO AFT45TNBR, ENDO AFT60TNBR, ENDO AFT45PLBR, ENDO AFT60PLBR，Ref ENDO AFT60PLBRRef ENDO AFT45TNRRef ENDO AFT45PLRRef ENDO AFT45PLBRRef ENDO AFT45TNBR
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 AFT60BKR EUDAMEDENDO AFT60PLBR EUDAMEDENDO AFT45TNR EUDAMEDENDO AFT45PLR EUDAMEDENDO AFT45PLBR EUDAMEDENDO AFT45TNBR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815842737 EUDAMED06953815842805 EUDAMED06953815842683 EUDAMED06953815842690 EUDAMED06953815842782 EUDAMED06953815842775 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 (6)
- EUDAMED 402604bb-da2c-4ecd-9438-333b25c7a509 61 fields · synced Oct 6, 2026
- EUDAMED 7a948f8f-061f-4fce-bf68-377e6bcde9f0 61 fields · synced May 17, 2026
- EUDAMED 132a87ac-758b-4a17-92f2-6b4d63141bf2 61 fields · synced May 18, 2026
- EUDAMED 1e291267-f4d2-4c74-84fd-a08a2f83d13e 61 fields · synced May 18, 2026
- EUDAMED b56ad491-61ef-42c3-91da-1f0ec122501f 61 fields · synced May 18, 2026
- EUDAMED 6aa3052d-d8c9-4e89-a67a-5b72a1b09959 61 fields · synced May 18, 2026