← Back to catalogue
CompreFLEX
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 351424Model CompreflexRef 351636Ref 351425Ref 351426Ref 351637Ref 351419Ref 351638Ref 351421Ref 351420Ref 351641Ref 351423Ref 351635Ref 351422
Identity
- Trade Name
- CompreFLEX EUDAMEDFDA UDI
- Generic Name
- General-purpose medical foam padding, single-use FDA UDI
- Device Name
- Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. FDA UDI
- Model / Reference
- Compreflex EUDAMED351424 EUDAMED351636 EUDAMED351425 EUDAMED351426 EUDAMED351637 EUDAMED351419 EUDAMED351638 EUDAMED351421 EUDAMED351420 EUDAMED351641 EUDAMED351423 EUDAMED351635 EUDAMED351422 EUDAMED14TC FDA UDI
- Description
- Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. FDA UDI
Identifiers
- Catalog Number
- 1411-TCT-L FDA UDI
- Primary DI / UDI-DI
- 00745129284947 EUDAMED00745129287061 EUDAMED00745129284954 EUDAMED00745129284961 EUDAMED00745129287078 EUDAMED00745129284893 EUDAMED00745129287085 EUDAMED00745129284916 EUDAMED00745129284909 EUDAMED00745129287115 EUDAMED00745129284930 EUDAMED00745129287054 EUDAMED00745129284923 EUDAMED00745129311063 FDA UDI
- Basic UDI-DI
- 0745129COMPREFLEX2L EUDAMED
- FDA Product Code
- MDR FDA UDI
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
- GMDN Term
- General-purpose medical foam padding, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5160 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose medical fibre paddingGeneral-purpose medical foam padding, single-use
CompreFLEX by Sigvaris, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose medical foam padding, single-use.
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- KENTEX — KENTRON HEALTH CARE, INC. · Class I
- Coolflex Arm X Large Long Left (BULK) — SIGVARIS, INC. · Class I
- 14 CompreFlex Arm — SIGVARIS, INC. · Class I
- 14 CompreFLEX Transition — SIGVARIS, INC. · Class I
- Coolflex Arm X Large Long Right (BULK) — SIGVARIS, INC. · Class I
- 12 MedaFit — SIGVARIS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sigvaris, Inc.
Sources (14)
- FDA UDI d0022a9e-703e-4cce-9493-ed7593c08529 36 fields · synced Aug 1, 2026
- EUDAMED 011ffa07-6c80-4ef8-8495-f79f15094e51 61 fields · synced Jul 8, 2026
- EUDAMED daab5f6f-efc6-4db2-af1b-c0a192ea1115 61 fields · synced Jul 9, 2026
- EUDAMED 8333ba59-d3a0-4934-9dd6-a26b05901445 61 fields · synced Jul 9, 2026
- EUDAMED 349b8eac-dd4e-4af2-9caa-4a2d7b1d16d4 61 fields · synced Jul 10, 2026
- EUDAMED e4ecba0f-1311-4ef0-9104-83b88bf96972 61 fields · synced Jul 13, 2026
- EUDAMED 66e0d6de-2d2b-416f-84bb-f910c4488e58 61 fields · synced Jul 13, 2026
- EUDAMED 3c0b342d-31ec-4ba9-a1c3-15d022ca9d41 61 fields · synced Jul 16, 2026
- EUDAMED 953e2e37-9079-4346-9801-1f59ef6383d1 61 fields · synced Jul 21, 2026
- EUDAMED c9890624-db1c-47e9-8c4d-bdd09d02e174 61 fields · synced Jul 24, 2026
- EUDAMED f38b371a-a550-4252-a6c6-62fbbdb52341 61 fields · synced Jul 24, 2026
- EUDAMED 43bdd811-1f3f-428d-a50f-eac7865c005d 61 fields · synced Jul 28, 2026
- EUDAMED fbbbda18-7db5-401c-8d47-16f3e793d5d7 61 fields · synced Jul 30, 2026
- EUDAMED 7aa215e7-3cbb-4ba2-b003-76c90f0ba394 61 fields · synced Jul 30, 2026