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Torso Body Sock

EUDAMEDFDA UDI

Class I (EU MDR)

Ref VTLSO-XS-12Ref FTLSO-LL-24Ref VTLSO-LG-20Ref VFTLSO-LL-24Ref FTLSO-MD-16

by Royal Knit, Inc

Identity

Trade Name
TORSO BODY SOCK EUDAMED
ROYAL TORSO BODY SOCK FDA UDI
Generic Name
Compression/pressure sock/stocking, single-use FDA UDI
Device Name
TORSO BODY SOCK EUDAMED
(22"-24") Torso Body Sock 1 Ply White X-Large Regular FDA UDI
Model / Reference
VTLSO-XS-12 EUDAMED
FTLSO-LL-24 EUDAMED
VTLSO-LG-20 EUDAMED
VFTLSO-LL-24 EUDAMED
FTLSO-MD-16 EUDAMED
TLSO-XL-24 FDA UDI
Description
(22"-24") Torso Body Sock 1 Ply White X-Large Regular FDA UDI

Identifiers

Catalog Number
TLSO-XL-24 FDA UDI
Primary DI / UDI-DI
+G296VTLSOXS120 EUDAMED
+G296FTLSOLL240 EUDAMED
+G296VTLSOLG200 EUDAMED
+G296VFTLSOLL240 EUDAMED
+G296FTLSOMD160 EUDAMED
G296TLSOXL240 FDA UDI
Basic UDI-DI
++G296BODYSOCKEE EUDAMED
FDA Product Code
FQL FDA UDI
EMDN Code
Y090699 DEVICES FOR BODY PROTECTION - OTHER EUDAMED
GMDN Term
Compression/pressure sock/stocking, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
880.5780 FDA UDI
Market of Registration
Denmark 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

Yes

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

No

FDA UDI

Torso Body Sock by Royal Knit, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Royal Knit, Inc
EUDAMED SRN
US-MF-000004427
Authorised Representative
Code of Practice AB SE-AR-000003002

Sources (6)

  • EUDAMED 9d2d608b-5760-4f0a-be88-4e77d70c9df7 61 fields · synced Jul 28, 2026
  • EUDAMED 0a1d7282-2976-4f60-b749-c0b1481a5cd2 61 fields · synced May 17, 2026
  • EUDAMED c3f530cc-c29f-4f04-9e57-691760b4ff74 61 fields · synced May 17, 2026
  • EUDAMED 4d4b1c8d-bec8-4701-99c6-caa304c580d1 61 fields · synced May 18, 2026
  • EUDAMED 85bf6b78-08e2-49eb-8e91-250370dd389f 61 fields · synced May 18, 2026
  • FDA UDI f38d7793-d8ba-4097-9230-be7a6ad34b55 34 fields · synced May 27, 2026