Surgical Drape
by Hubei V-Medical Products Co., Ltd. 5 variants
Ref 1034SAPModel 45x75cm 75x90cm
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697023378sSurgicalDrapeXY 16942013205151 | Date10 Jun 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Steril Surgical Drapes
- Model / reference
- 45x75cm 75x90cm, 1034SAP
- Primary DI / UDI-DI
- 16942013205151
- Basic UDI-DI
- 697023378sSurgicalDrapeXY
- Direct marketing DI
- 06942013205154
- EMDN code
- T02010101 Incision drapes, without antibacterial agent
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000011268
- Authorised representative
- RAFFIN MEDICAL FR-AR-000004632
Other devices from Hubei V-Medical Products Co., Ltd.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No