Identity
- Trade Name
- IPER LA GRANDE I EUDAMEDIper la grande i - certotti nasali EUDAMED
- Device Name
- INSTANT PACK ICE EUDAMEDNASAL PATCH EUDAMED
- Model / Reference
- GIS118233 EUDAMEDCTN118431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08029513118233 EUDAMED08029513118431 EUDAMED
- Basic UDI-DI
- B-08029513118233 EUDAMED8017990CNYGY EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMEDR9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Italy 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
Category: Hot/cold therapy pack, reusable
Iper La Grande I by Eurosirel Spa — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- ACCU-THERM — Medline Industries, LP · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08029513118233 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08029513118233 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (2)
- EUDAMED 734040e0-7e6e-4577-8f6b-7dc1f7f02f7e 61 fields · synced Jul 18, 2026
- EUDAMED f141e00a-ede0-4e8c-b419-7733c5fb1037 61 fields · synced May 18, 2026