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ENDO REACH RLC Reload Units
EUDAMEDClass IIb (EU MDR)
Ref ENDO RLC6040LModel ENDO RLC4525L
Identity
- Trade Name
- ENDO REACH RLC Reload Units EUDAMED
- Device Name
- Single Use Loading Units for Endoscopic Linear Cutting Staplers EUDAMED
- Model / Reference
- ENDO RLC4525L EUDAMEDENDO RLC6040L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815841242 EUDAMED
- Basic UDI-DI
- 69538158H3632 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 RLC 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 | 69538158H3632 | 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 910a7541-ebea-44c2-9579-1aa446fc0bd4 61 fields · synced Jun 18, 2026