CoolSculpting Elite Umbilical Cable 2m
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- CoolSculpting Elite Umbilical Cable 2m EUDAMEDCoolSculpting Umbilical Cable Assembly 2m FDA UDI
- Generic Name
- Cryolipolysis body contouring system applicator FDA UDI
- Device Name
- CoolSculpting Elite System EUDAMEDCoolSculpting Umbilical Cable Assembly 2m FDA UDI
- Model / Reference
- CS-A3-UMB-00 EUDAMEDFDA UDI
- Description
- CoolSculpting Umbilical Cable Assembly 2m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816417021688 EUDAMEDFDA UDI
- Basic UDI-DI
- 0816417020001SL EUDAMED
- Direct Marketing DI
- 00816417021688 EUDAMED
- FDA Product Code
- OOK FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Cryolipolysis body contouring system applicator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4340 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Hot/cold therapy pack, reusable
CoolSculpting Elite Umbilical Cable 2m by Zeltiq Aesthetics, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0816417020001SL | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Zeltiq Aesthetics, Inc.
- EUDAMED SRN
- US-MF-000004536
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (2)
- EUDAMED bc48486e-df29-49da-9579-89194849fbed 61 fields · synced Jun 17, 2026
- FDA UDI 48ea8daf-49ac-463c-8447-3ce2bf53e040 34 fields · synced May 22, 2026