Identity
- Trade Name
- Holder EUDAMEDFDA UDI
- Generic Name
- Medical table clamp FDA UDI
- Device Name
- Holder EUDAMEDCryohandle stabilizer FDA UDI
- Model / Reference
- FAG3000000 EUDAMEDFDA UDI
- Description
- Cryohandle stabilizer FDA UDI
Identifiers
- Catalog Number
- FAG3000000 FDA UDI
- Primary DI / UDI-DI
- 07290015487153 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290015487153 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
- GMDN Term
- Medical table clamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Holder by Icecure Medical Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290015487153 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IceCure Medical Ltd.
- EUDAMED SRN
- IL-MF-000026406
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED ad931ba3-c4b1-46e4-9bb2-8a66a602437d 61 fields · synced Jun 18, 2026
- FDA UDI e5b72859-58fd-4339-be61-7b083bef8a97 36 fields · synced May 30, 2026