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SIMPLE 3D Insole
EUDAMEDClass I (EU MDR)
Ref 61009-FModel 61001,61002,61003,61004,61005,61006,61015,61016,61017,62005,62007,62009,62010,62011,62012,62013,62014,62015,62034,62047
Identity
- Trade Name
- SIMPLE 3D Insole EUDAMED
- Device Name
- SIMPLE Walker B2,SIMPLE Walker B2,Front pressure relief shoe BF4,Rear pressure relief shoe BF5,Post-Op Shoe BF6,Lace-up Ankle Brace A2,SIMPLE Air Heel A1,SIMPLE Ankle Brace A3,SIMPLE Ankle Brace A4,SIMPLE Lace-up Ankle Brace A13,Cryo Treat Ankle EUDAMED
- Model / Reference
- 61001,61002,61003,61004,61005,61006,61015,61016,61017,62005,62007,62009,62010,62011,62012,62013,62014,62015,62034,62047 EUDAMED61009-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244542356 EUDAMED
- Basic UDI-DI
- 697124454AnkleOrthosesEM EUDAMED
- Direct Marketing DI
- 06971244542356 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SIMPLE 3D Insole by Simple Medical (Shenzhen) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697124454AnkleOrthosesEM | Class I | Active |
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Manufacturer
- Manufacturer
- Simple Medical (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000013198
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED e60a48ba-f248-424a-ba33-73d534ffb1fd 61 fields · synced Jul 10, 2026