Identity
- Trade Name
- Morpheus8 Applicator FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system applicator FDA UDI
- Device Name
- Morpheus8 Bipolar Radiofrequency Applicator EUDAMEDMorpheus8 Applicator FDA UDI
- Model / Reference
- AG607401A EUDAMEDFDA UDI
- Description
- Morpheus8 Applicator FDA UDI
Identifiers
- Catalog Number
- AG607401A FDA UDI
- Primary DI / UDI-DI
- 07290016633412 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290016633412 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12040218 ENDERMOLOGY TREATMENTS EUDAMED
- GMDN Term
- Radio-frequency skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Radio-frequency skin surface treatment system applicator
Morpheus8 Applicator by Inmode MD , Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K192695 also covers:
K200947 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (2)
- FDA UDI 3f1b0ed6-ed49-4be1-9f21-f90817aded94 37 fields · synced Aug 2, 2026
- EUDAMED bbfe1bf0-52b0-4337-8dc7-205e43710a27 61 fields · synced Aug 2, 2026