Cubre Mangas Desechable Sellado a Mano de Polietileno 0.02mm LDPE
by Uhealth Medical (Beijing) Products Co., Ltd. 3 variants
Ref 4100V, 4100A, 4500Y, 4100R, 4500V, 4500A
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 | Number69741004241003N | Date11 Dec 2025 | 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- Withdrawn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
- Trade Name
- Cubre Mangas Desechable Sellado a Mano de Polietileno 0.02mm LDPECubre Mangas de Polietileno LDPE Virgen
- Device Name
- Disposable LDPE Sleeve Covers Hand MadeLDPE Oversleeves Hand Made
- Model / Reference
- 4100V, 4100A, 4500Y, 4100R, 4500V, 4500A
- Primary DI / UDI-DI
- 06974100421017, 06974100420553, 06974100420997, 06974100420577, 06974100422076, 06974100420584
- Basic UDI-DI
- 69741004241003N, 69741004245004A
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000043700
- Authorised representative
- LUHEPA INTERNACIONAL, S.L. ES-AR-000043668
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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