SIMPLE Post-Op Shoe BF6
by Simple Medical (Shenzhen) Limited China EUDAMED
Ref 61017-SModel 61001,61002,61003,61004,61005,61006,61015,61016,61017,62005,62007,62009,62010,62011,62012,62013,62014,62015,62034,62047
EMDN Y06120601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697124454AnkleOrthosesEM | Date9 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 61001, 61002, 61003, 61004, 61005, 61006, 61015, 61016, 61017, 62005, 62007, 62009, 62010, 62011, 62012, 62013, 62014, 62015, 62034, 62047, 61017-S
- Primary DI / UDI-DI
- 06971244542608
- Basic UDI-DI
- 697124454AnkleOrthosesEM
- Direct Marketing DI
- 06971244542608
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000013198
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Simple Medical (Shenzhen) Limited
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED e5a19ebd-c5e1-4a91-ad3e-07cbbda08fc2