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CERAGEM Master V4
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref E4KN202490Model CGM MB-1901
Identity
- Trade Name
- Master V4 EUDAMEDCERAGEM Master V4 FDA UDI
- Generic Name
- Massage table/couch, line-powered FDA UDI
- Device Name
- Master V4 EUDAMED
- Model / Reference
- CGM MB-1901 EUDAMEDFDA UDIE4KN202490 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809494000075 EUDAMEDFDA UDI
- Basic UDI-DI
- 880949400CGMMB-1901NZ EUDAMED
- Direct Marketing DI
- 08809494000075 EUDAMED
- 510(k) Number
- K202113 FDA UDI
- FDA Product Code
- JFB FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Massage table/couch, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5880 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Massage table/couch, line-powered
CERAGEM Master V4 by Ceragem Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ceragem Co., Ltd.
Sources (2)
- FDA UDI c21257f2-c917-431b-bc6a-23337da94f36 33 fields · synced Sep 30, 2026
- EUDAMED 086d26ee-c15f-4d58-8dd3-69985e8b56c6 61 fields · synced Jul 8, 2026