Health Design Sof Touch Post Op Shoe
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Health Design Soft Touch Post Op Shoe EUDAMEDHealth Design Sof Touch Post Op Shoe FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Device Name
- Men's Extra-Large Black FDA UDI
- Model / Reference
- HD-PO-ST8 EUDAMEDFDA UDI
- Description
- Men's Extra-Large Black FDA UDI
Identifiers
- Catalog Number
- HD-PO-ST8 FDA UDI
- Primary DI / UDI-DI
- 00609271001572 EUDAMEDFDA UDI
- Basic UDI-DI
- 0609271001574Z EUDAMED
- FDA Product Code
- KNP FDA UDI
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
- GMDN Term
- Orthotic shoe, non-customized FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthotic shoe, non-customized
Health Design Sof Touch Post Op Shoe by DARCO International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic shoe, non-customized.
- VIVE — VIVE HEALTH LLC · Class I
- DARCO® Relief Dual® + Toe Cap — Darco (Europe) GmbH · Class I
- DARCO® MedSurg Pro® — Darco (Europe) GmbH · Class I
- Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · Class I
- DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
- DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
- DARCO® WCS™ — Darco (Europe) GmbH · Class I
- Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (2)
- FDA UDI 322424e5-2254-45e0-a722-fde609f39f3a 34 fields · synced Oct 7, 2026
- EUDAMED 55f0be90-bc3a-4fe9-a9d2-6b03fb135572 61 fields · synced Oct 7, 2026