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Solidea

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 0338B8

by Calzificio Pinelli Srl

Identity

Trade Name
CATHERINE CCL.2 PLUS LINE PUNTA APERTA EUDAMED
SOLIDEA FDA UDI
Generic Name
Compression/pressure sock/stocking, reusable FDA UDI
Device Name
THERAPEUTIC LINE EUDAMED
CATHERINE CCL.2 PLUS LINE OPEN TOE, SIZE M, NATUR, GRADUATED COMPRESSION 25/32 mmHg STAY UP STOCKING FOR SUSPENDER FDA UDI
Model / Reference
0338B8 EUDAMED
038412 FDA UDI
Description
CATHERINE CCL.2 PLUS LINE OPEN TOE, SIZE M, NATUR, GRADUATED COMPRESSION 25/32 mmHg STAY UP STOCKING FOR SUSPENDER FDA UDI

Identifiers

Catalog Number
0338B8 FDA UDI
Primary DI / UDI-DI
08300496038412 EUDAMEDFDA UDI
Basic UDI-DI
83004960080DDYU EUDAMED
FDA Product Code
DWL FDA UDI
EMDN Code
M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
GMDN Term
Compression/pressure sock/stocking, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.5780 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

Category: Compression/pressure sock/stocking, reusable

Solidea by Calzificio Pinelli Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Compression/pressure sock/stocking, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI 3500577f-d9a2-46f0-bb73-129e0a2e2a20 34 fields · synced Aug 1, 2026
  • EUDAMED 65b8583c-897f-43de-9a6e-297f7f4d95f4 61 fields · synced Aug 1, 2026