Zentrum
by Xiantao Yinhong Protective Products Co., Ltd 34 variants
Ref 140x240cm, 210*150cm, 80x210cm, XL, 16x39cm, 21inch, 210x150cm, 100x210cm, 140x230cm, Round face cap, S, XXL, M, LModel 50x70cm, 75x210cm,100x200cm, Customized Sizes, M,L,XL,XXL,XXXL,XXXXL,Customized Sizes, 15*39cm,15*40cm,17*41cm, 17*46cm, Customized Sizes, 17” 18” 19” 20” 21” 24”,Customized Sizes, XS,S,M,L,XL,XXL,XXXL,Customized Sizes
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697300303YH0069E | Date11 Dec 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Bed Cover SheetIsolation gownShoe CovercapScrub suit
- Model / Reference
- 50x70cm, 75x210cm, 100x200cm, Customized Sizes, 140x240cm, 210*150cm, 80x210cm, M, L, XL, XXL, XXXL, XXXXL, 15*39cm, 15*40cm, 17*41cm, 17*46cm, 16x39cm, 17” 18” 19” 20” 21” 24”, 21inch, 210x150cm, 100x210cm, 140x230cm, Round face cap, XS, S
- Primary DI / UDI-DI
- 16973003030675, 16973003030545, 06973003030562, 16973003030569, 06973003030692, 16973003030163, 06973003030722, 16973003030620, 06973003030654, 16973003030156, 06973003030708, 16973003030729, 06973003030166, 06973003030227, 06973003030548, 06973003030258, 06973003030678, 06973003030142, 16973003030224, 06973003030623, 06973003030524, 16973003030743, 06973003030739, 06973003030579, 16973003030149, 06973003030685, 16973003030590, 16973003030682, 16973003030668, 16973003030644, 16973003030651, 16973003030170, 16973003030231, 16973003030521, 16973003030255, 16973003030262, 06973003030159, 06973003030838, 06973003030845, 16973003030194, 06973003030784, 16973003030828, 06973003030814, 06973003030197, 16973003030781, 06973003030791, 16973003030798, 06973003030807, 16973003030750, 06973003030760
- Basic UDI-DI
- 697300303YH0069E, 697300303YH00296, 697300303ShoeCoverD8, 697300303YH00398, 697300303YH0059C
- EMDN Code
- T030502, T0299, T0208, T0207
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000009777
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiantao Yinhong Protective Products Co., Ltd
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- 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