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Affirm 14mm Tip
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 100-7004-814
by Cynosure LLC
Identity
- Trade Name
- Affirm 14mm Tip EUDAMEDAffirm, 14mm Tip FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- Affirm 14mm Tip EUDAMEDAffirm, 14mm Tip FDA UDI
- Model / Reference
- 100-7004-814 EUDAMEDFDA UDI
- Description
- Affirm, 14mm Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494100513 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841494100513 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Affirm 14mm Tip by Cynosure, LLC — Class IIb — 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-00841494100513 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cynosure LLC
- EUDAMED SRN
- US-MF-000010200
- Authorised Representative
- Cynosure B.V. NL-AR-000009566
Sources (2)
- EUDAMED fd0e10f4-e6a5-4c3b-b97f-2aaaa0910b6c 61 fields · synced Jul 11, 2026
- FDA UDI 730a4179-10ff-49b6-9da0-714d88f5d257 34 fields · synced May 30, 2026