Articulating Paper
by ZOGEAR Medical Co., Ltd. 6 variants
Ref AP001-6Model AP001-1A,AP001-2A,AP001-1B,AP001-4,AP001-5,AP001-6,AP001-7,AP001-8,AP001-9,AP001-10,AP001-11,AP001-12,AP001-13,AP001-15
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 | Number697484312AP001DT 06974843121922 | Date5 Nov 2026 | 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- Withdrawn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
- Model / Reference
- AP001-1A, AP001-2A, AP001-1B, AP001-4, AP001-5, AP001-6, AP001-7, AP001-8, AP001-9, AP001-10, AP001-11, AP001-12, AP001-13, AP001-15
- Primary DI / UDI-DI
- 06974843121922
- Basic UDI-DI
- 697484312AP001DT
- EMDN Code
- Q01020201 Articulation papers
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000012353
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from ZOGEAR Medical Co., Ltd.
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