ThermaCare

EUDAMED

Class IIa (EU MDR)

Ref F00573301752WRef F00573304029Ref F00573304027Ref F00573301524WRef F00573301015WRef 300056Ref F00573301053WRef F00573301536WRef F00573304030Ref F00573301515WRef F00573304002Ref F00573301723XRef F00573304013Ref F00573304004Ref F00573304014Ref F00573301726WRef F00573301028WRef F00573301023WRef 300059Ref 300020Ref F00573304033Ref F00573304001Ref F00573301024WRef F00573301026WRef F00573304043Ref F00573304045Ref F00573304032Ref 300057Ref F00573301714W

by Angelini Pharma Inc.

Identity

Trade Name: ThermaCare EUDAMED
Device Name: ThermaCare (Flexible Use for larger body areas 8 hours) EUDAMED
ThermaCare (for Knee pain 8 hours) EUDAMED
ThermaCare (for Lower Back and Hip 8 hours) EUDAMED
ThermaCare (for Neck Shoulder and Wrist 8 hours) EUDAMED
ThermaCare (for Neck Shoulder and Wrist 12 hours) EUDAMED
ThermaCare (Flexible Use for localized pain 8 hours) EUDAMED
ThermaCare (Sport 8 hours) EUDAMED
ThermaCare (for Menstrual pain 8 hours) EUDAMED
Model / Reference: F00573301752W EUDAMED
F00573304029 EUDAMED
F00573304027 EUDAMED
F00573301524W EUDAMED
F00573301015W EUDAMED
300056 EUDAMED
F00573301053W EUDAMED
F00573301536W EUDAMED
F00573304030 EUDAMED
F00573301515W EUDAMED
F00573304002 EUDAMED
F00573301723X EUDAMED
F00573304013 EUDAMED
F00573304004 EUDAMED
F00573304014 EUDAMED
F00573301726W EUDAMED
F00573301028W EUDAMED
F00573301023W EUDAMED
300059 EUDAMED
300020 EUDAMED
F00573304033 EUDAMED
F00573304001 EUDAMED
F00573301024W EUDAMED
F00573301026W EUDAMED
F00573304043 EUDAMED
F00573304045 EUDAMED
F00573304032 EUDAMED
300057 EUDAMED
F00573301714W EUDAMED

Identifiers

Primary DI / UDI-DI: 08000036024638 EUDAMED
08000036029312 EUDAMED
08000036029299 EUDAMED
08000036024584 EUDAMED
08000036026434 EUDAMED
08000036030547 EUDAMED
08000036024829 EUDAMED
08000036027394 EUDAMED
08000036029329 EUDAMED
08000036026458 EUDAMED
08000036025567 EUDAMED
08000036026410 EUDAMED
08000036027837 EUDAMED
08000036025581 EUDAMED
08000036027844 EUDAMED
08000036024614 EUDAMED
08000036024577 EUDAMED
08000036026366 EUDAMED
08000036030554 EUDAMED
08000036026533 EUDAMED
08000036029350 EUDAMED
08000036025550 EUDAMED
08000036024560 EUDAMED
08000036024812 EUDAMED
08000036030820 EUDAMED
08000036030936 EUDAMED
08000036029343 EUDAMED
08000036030561 EUDAMED
08000036026403 EUDAMED
Basic UDI-DI: 08600065397TC2FLXL80000J8 EUDAMED
08600065397TC8KE8000000QT EUDAMED
08600065397TC3LBH800000WF EUDAMED
08600065397TC5NSW800000KU EUDAMED
08600065397TC6NSW120000JL EUDAMED
08600065397TC1FLX8000006U EUDAMED
08600065397TC9SP800000064 EUDAMED
08600065397TC4MENS80000JF EUDAMED
Unit of Use DI: 08000036028773 EUDAMED
08000036028377 EUDAMED
08000036028582 EUDAMED
08000036028742 EUDAMED
08000036028629 EUDAMED
08000036028667 EUDAMED
08000036028643 EUDAMED
08000036028636 EUDAMED
08000036028551 EUDAMED
08000036028865 EUDAMED
08000036028483 EUDAMED
08000036028872 EUDAMED
08000036028728 EUDAMED
08000036028599 EUDAMED
08000036028391 EUDAMED
08000036028766 EUDAMED
08000036028452 EUDAMED
08000036028407 EUDAMED
08000036028421 EUDAMED
08000036029800 EUDAMED
08000036028520 EUDAMED
EMDN Code: M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Italy EUDAMED
France EUDAMED
Germany EUDAMED
Netherlands EUDAMED
Spain EUDAMED
Poland EUDAMED
Belgium EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Hot/cold therapy pack, reusable

ThermaCare by Angelini Pharma Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Hot/cold therapy pack, reusable.

Future Generation Medical — Global International L. L. C. · Class I
Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
PRONTO MED — Eurosirel Spa · Class IIa
HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
HotCold Pack reusable — Bevaplast B.V. · Class I
reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	08600065397TC2FLXL80000J8	Class IIa	Active

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Manufacturer

Manufacturer: Angelini Pharma Inc.
EUDAMED SRN: US-MF-000038346
Authorised Representative: Angelini Pharma S.p.A. IT-AR-000028426

Sources (29)

EUDAMED 0f3c35eb-5b7a-4185-bcf4-6bf54b33343b 61 fields · synced Sep 18, 2026
EUDAMED adb0dbc6-5954-48cb-bd4e-3d4fb60442fc 61 fields · synced May 11, 2026
EUDAMED fe16e253-f3fa-4b71-9903-0df2d54080cf 61 fields · synced May 16, 2026
EUDAMED ec49e49a-aeda-4df5-8228-a4168dbc1aae 61 fields · synced May 16, 2026
EUDAMED fdb4efe5-9c6a-460a-bac4-a9d5d2c2466b 61 fields · synced May 17, 2026
EUDAMED 882f0505-868b-49d1-a175-4c4a6f80dfae 61 fields · synced May 17, 2026
EUDAMED 4455accf-db12-42ea-889b-38015945e7ab 61 fields · synced May 17, 2026
EUDAMED 30e19e3b-0825-48fd-8664-ab08cf8dc8f9 61 fields · synced May 17, 2026
EUDAMED 5c07c375-6ffd-4ef7-8e16-3efb83e82325 61 fields · synced May 17, 2026
EUDAMED 125f8e7f-9761-449c-9bfc-ab0db7496fc5 61 fields · synced May 17, 2026
EUDAMED 2938e580-fce4-49c8-b358-d2f9c120f922 61 fields · synced May 17, 2026
EUDAMED 7a67eb63-ec45-4578-b8f7-7079083c5034 61 fields · synced May 17, 2026
EUDAMED 43175eeb-c368-493c-bd46-59802d5ee7df 61 fields · synced May 17, 2026
EUDAMED cf4a61cc-9215-48c5-a2d2-c09d3bea8a97 61 fields · synced May 17, 2026
EUDAMED 1163299d-2170-4445-aaa5-6104a8ccdac8 61 fields · synced May 17, 2026
EUDAMED 22f85639-af05-4c14-83ae-1ee55d88e041 61 fields · synced May 17, 2026
EUDAMED 5f024728-463b-43de-aef9-bbd41005428c 61 fields · synced May 18, 2026
EUDAMED 6b9c3117-c779-4d86-8697-b69987300c9f 61 fields · synced May 18, 2026
EUDAMED fc2e088f-4f39-4887-aa61-6930c398c87b 61 fields · synced May 18, 2026
EUDAMED ef24399b-546b-41c7-9d21-ffb66b56badb 61 fields · synced May 18, 2026
EUDAMED 13743000-7535-4306-818d-c391b3a5e555 61 fields · synced May 18, 2026
EUDAMED 89a2a6f9-e2e1-4160-b54a-a19889f7ae05 61 fields · synced May 18, 2026
EUDAMED 1454b9c0-25b5-41ef-a2ab-efb621d0e670 61 fields · synced May 18, 2026
EUDAMED 687ab6c8-3570-4102-acf4-6e736cff98a5 61 fields · synced May 18, 2026
EUDAMED 5af27ff7-a1c9-423a-8ebe-4d47402b17f9 61 fields · synced May 18, 2026
EUDAMED 8d1ca85b-4933-4002-8ea6-7843de6673b1 61 fields · synced May 18, 2026
EUDAMED 3849ebe9-8f6e-412c-9768-802edd779f9b 61 fields · synced May 18, 2026
EUDAMED b4d152da-26eb-452c-ae5f-50ca2eeb8f3f 61 fields · synced May 18, 2026
EUDAMED 0d82044b-ee49-4b1a-a9a1-e89e67111318 61 fields · synced May 19, 2026