Surgiclean®
by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED
Ref MPH-SG-0.5Model 0.5g/Piece, 1.0g/Piece, 2.0g/Piece, 3.0g/Piece, 5.0g/Piece EMDN M040599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69360201248S | Date5 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- C544578 Issued
Technical documentation EU MDR
- Notified body
- DNV Product Assurance AS 2460
- Issued
- 3 Dec 2024
- Expires
- 2 Dec 2029
- C637543 Issued
Quality management system EU MDR
- Notified body
- DNV Product Assurance AS 2460
- Issued
- 3 Dec 2024
- Expires
- 2 Dec 2029
Specification
- Device Name
- MPH Absorbable Hemostatic Particles
- Model / Reference
- 0.5g/Piece, 1.0g/Piece, 2.0g/Piece, 3.0g/Piece, 5.0g/Piece, MPH-SG-0.5
- Primary DI / UDI-DI
- 06936020113007
- Basic UDI-DI
- 69360201248S
- EMDN Code
- M040599 Haemostatic dressings - other
- Device Class
- Class III
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014098
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Hangzhou Singclean Medical Products Co., Ltd.
See all devices from Hangzhou Singclean Medical Products Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 4bda7a59-d4c6-43d2-bf1e-533e660420f4