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ENDO REACH SRC Reload Units
EUDAMEDClass IIb (EU MDR)
Ref ENDO SRC6035BLModel ENDO RLC4525LRef ENDO SRC6040BRModel ENDO RLC4525RRef ENDO SRC4525RRef ENDO SRC4548BLRef ENDO SRC4525BLRef ENDO SRC4535LRef ENDO SRC4548LRef ENDO SRC4535BLRef ENDO SRC4535R
Identity
- Trade Name
- ENDO REACH SRC Reload Units EUDAMED
- Device Name
- Single Use Loading Units for Endoscopic Linear Cutting Staplers EUDAMED
- Model / Reference
- ENDO RLC4525L EUDAMEDENDO SRC6035BL EUDAMEDENDO RLC4525R EUDAMEDENDO SRC6040BR EUDAMEDENDO SRC4525R EUDAMEDENDO SRC4548BL EUDAMEDENDO SRC4525BL EUDAMEDENDO SRC4535L EUDAMEDENDO SRC4548L EUDAMEDENDO SRC4535BL EUDAMEDENDO SRC4535R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815842522 EUDAMED06953815842645 EUDAMED06953815842355 EUDAMED06953815842492 EUDAMED06953815842461 EUDAMED06953815842232 EUDAMED06953815842249 EUDAMED06953815842478 EUDAMED06953815842362 EUDAMED
- Basic UDI-DI
- 69538158H3632 EUDAMED69538158H3836 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 SRC 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 (9)
- EUDAMED 081a7d41-f9d1-41e9-b12f-1691fa417c6c 61 fields · synced Oct 7, 2026
- EUDAMED 97d158d8-de1b-419c-98bf-6cd579e92b4c 61 fields · synced May 17, 2026
- EUDAMED 62a4bde5-74fb-4713-b4c1-1798171595f2 61 fields · synced May 17, 2026
- EUDAMED 3ebb257d-7731-44e6-b641-b6a280e67631 61 fields · synced May 18, 2026
- EUDAMED 6ad66ecf-2a86-4cdb-823c-6f3f0ef38b43 61 fields · synced May 18, 2026
- EUDAMED 4a16fdec-7e83-4972-b118-772b06af93bd 61 fields · synced May 18, 2026
- EUDAMED 48887782-8916-4255-b61c-90b7a73e4836 61 fields · synced May 18, 2026
- EUDAMED 1e6815b7-5499-4ecb-b1d7-f6ce52634d33 61 fields · synced May 18, 2026
- EUDAMED dc2f2018-a0c0-4714-9ac6-ab21ce18e876 61 fields · synced May 19, 2026