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CoolSculpting Elite Applicator Curve 80 (C80)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CS-A3-08C-00
Identity
- Trade Name
- CoolSculpting Elite Applicator Curve 80 (C80) EUDAMEDCoolSculpting System Applicators Curve 80 (C80) FDA UDI
- Generic Name
- Cryolipolysis body contouring system applicator FDA UDI
- Device Name
- CoolSculpting Elite System EUDAMEDCoolSculpting System Applicators Curve 80 (C80) FDA UDI
- Model / Reference
- CS-A3-08C-00 EUDAMEDFDA UDI
- Description
- CoolSculpting System Applicators Curve 80 (C80) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816417021558 EUDAMEDFDA UDI
- Basic UDI-DI
- 0816417020001SL EUDAMED
- Direct Marketing DI
- 00816417021558 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hot/cold therapy pack, reusable
CoolSculpting Elite Applicator Curve 80 (C80) by Zeltiq Aesthetics, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 a7f0d0b7-af46-4d84-8e7a-1ca35b5ceed3 61 fields · synced Jun 18, 2026
- FDA UDI fc9da82b-9c5f-4cc5-8bf7-9b336f306b7b 34 fields · synced May 29, 2026