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Linear Cutter Reloads
EUDAMEDClass IIb (EU MDR)
Ref OCR4530Ref OCR4535Ref OCR4540Ref OCR4538Ref OCR6030Ref OCR6038Ref OCR6025Ref OCR6040
Identity
- Trade Name
- Linear Cutter Reloads EUDAMED
- Device Name
- Powered Endoscopic Staplers EUDAMED
- Model / Reference
- OCR4530 EUDAMEDOCR4535 EUDAMEDOCR4540 EUDAMEDOCR4538 EUDAMEDOCR6030 EUDAMEDOCR6038 EUDAMEDOCR6025 EUDAMEDOCR6040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972304750930 EUDAMED16972304750947 EUDAMED16972304750961 EUDAMED16972304750954 EUDAMED16972304750992 EUDAMED16972304751012 EUDAMED16972304750985 EUDAMED16972304751029 EUDAMED
- Basic UDI-DI
- 697230475000875 EUDAMED
- EMDN Code
- H020301040101,H020301040102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMEDSlovenia EUDAMEDFrance 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
Linear Cutter Reloads by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. — 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 | 697230475000875 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014087
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED 33ab8f69-cea5-4066-b282-60922ae3c73e 61 fields · synced Aug 2, 2026
- EUDAMED 62102317-d092-414c-9acc-b745e06b6fe0 61 fields · synced May 18, 2026
- EUDAMED 94e87dfb-a9e7-43e6-8886-b4e7aab7e244 61 fields · synced Jun 20, 2026
- EUDAMED bd7cc804-1a5b-4df6-8bdd-78ecf63d0a2b 61 fields · synced Jul 12, 2026
- EUDAMED 283c1bd3-63be-407d-8493-e9b76ad120c9 61 fields · synced Jul 14, 2026
- EUDAMED bdb69f80-6f27-44e6-8bee-afe516ade3ba 61 fields · synced Jul 15, 2026
- EUDAMED 32a4acf3-bdd6-4cc2-947e-98cf7a9f8c7f 61 fields · synced Jul 20, 2026
- EUDAMED 4add2a49-0e97-4f89-8d43-2f6052dc8f2f 61 fields · synced Aug 2, 2026