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Optiform Feel
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OFE1CHHModel OPTIFORM FEEL
Identity
- Trade Name
- Optiform Feel EUDAMEDFDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- OPTIFORM FEEL CH-H CCL1. A custom sewn device from a flat knit compression template in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device. FDA UDI
- Model / Reference
- OFE1CHH EUDAMEDFDA UDIOPTIFORM FEEL EUDAMED
- Description
- OPTIFORM FEEL CH-H CCL1. A custom sewn device from a flat knit compression template in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- OFE1CHH FDA UDI
- Primary DI / UDI-DI
- 07613378135828 EUDAMEDFDA UDI
- Basic UDI-DI
- 7613378OPTIFEELJ3 EUDAMED
- FDA Product Code
- FQL FDA UDI
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
- GMDN Term
- Compression/pressure tubular garment FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5780 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Compression/pressure tubular garment
Optiform Feel by Sigvaris, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure tubular garment.
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Vive — VIVE HEALTH LLC · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Vive — VIVE HEALTH LLC · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Sigvaris, Inc.
Sources (2)
- FDA UDI 92a4b145-d6a8-4312-a551-31b8961e7626 36 fields · synced Oct 5, 2026
- EUDAMED 7a0e45ac-b7df-4a62-9653-0622e5d3fa15 61 fields · synced Oct 5, 2026