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SIMPLE Rear pressure relief shoe BF5
EUDAMEDClass I (EU MDR)
Ref 61016-MModel 61001,61002,61003,61004,61005,61006,61015,61016,61017,62005,62007,62009,62010,62011,62012,62013,62014,62015,62034,62047
Identity
- Trade Name
- SIMPLE Rear pressure relief shoe BF5 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 EUDAMED61016-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244542554 EUDAMED
- Basic UDI-DI
- 697124454AnkleOrthosesEM EUDAMED
- Direct Marketing DI
- 06971244542554 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
Category: Ankle/foot orthosis
SIMPLE Rear pressure relief shoe BF5 by Simple Medical (Shenzhen) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 b2d88b37-51a3-4252-8be4-09c867a5e45b 61 fields · synced Jul 31, 2026