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CoolSculpting Elite Control Unit
EUDAMEDClass IIb (EU MDR)
Ref CS-S3-001-I-00Ref CS-S3-001-D-00
Identity
- Trade Name
- CoolSculpting Elite Control Unit EUDAMED
- Device Name
- CoolSculpting Elite System EUDAMED
- Model / Reference
- CS-S3-001-I-00 EUDAMEDCS-S3-001-D-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816417022326 EUDAMED00816417021695 EUDAMED
- Basic UDI-DI
- 0816417020001SL EUDAMED
- Direct Marketing DI
- 00816417022326 EUDAMED00816417021695 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMEDIreland 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
CoolSculpting Elite Control Unit by Zeltiq Aesthetics, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0816417020001SL | Class IIb | Active |
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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 2a4a0890-bfeb-4a10-b6f1-be292f77d47d 61 fields · synced Jul 13, 2026
- EUDAMED 4e46e277-cffd-4ac0-a04c-72b1c89bc74c 61 fields · synced May 18, 2026