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Cold Therapy Bag

EUDAMED

Class I (EU MDR)

Ref 13422-00-01Ref 70582-00-01Ref 00144-0612-06Model 100

by Professional Products, Inc.

Identity

Trade Name
Cold Therapy Bag EUDAMED
Device Name
Direct Stick FirstIce Cryotherapy Bag EUDAMED
Q4 FirstIce Cryotherapy Bag EUDAMED
First Ice Direct Stick Bags with 4-Slot DFP EUDAMED
Model / Reference
13422-00-01 EUDAMED
70582-00-01 EUDAMED
100 EUDAMED
00144-0612-06 EUDAMED

Identifiers

Primary DI / UDI-DI
08836913337450 EUDAMED
08836912744990 EUDAMED
08836913463876 EUDAMED
Basic UDI-DI
088369113422E7 EUDAMED
088369170582GB EUDAMED
088369114499 EUDAMED
EMDN Code
Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Cold Therapy Bag by Professional Products, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000019828
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED 61f6eda2-a0e6-4e74-be05-f8827339d901 61 fields · synced Jul 22, 2026
  • EUDAMED e7a52f64-d25e-4f03-85ac-9792bfbae379 61 fields · synced May 17, 2026
  • EUDAMED 1c94d0fc-5119-4c93-a34b-9cb2f880e9b8 61 fields · synced May 18, 2026