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Sterile Surgical Incision Drapes
EUDAMEDClass I (EU MDR)
Ref G01150200Model Type G01
Identity
- Trade Name
- Sterile Surgical Incision Drapes EUDAMED
- Device Name
- Sterile Surgical Incision Drapes EUDAMED
- Model / Reference
- Type G01 EUDAMEDG01150200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489891002 EUDAMED
- Basic UDI-DI
- 697548989XLG012Q EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Sterile Surgical Incision Drapes by Shandong Shinrise Medical Supplies Co., Ltd. — Class I — 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 | 697548989XLG012Q | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Shinrise Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031315
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 51d0cdf6-80cf-4bbc-bba2-836100792a43 61 fields · synced Jun 18, 2026