Identity
- Trade Name
- ME04 EUDAMEDCASE MEDICAL FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- ME03 EUDAMEDMEDICAL ENTERPRISES BATTERY SET FDA UDI
- Model / Reference
- ME03 EUDAMEDME04 EUDAMEDFDA UDI
- Description
- MEDICAL ENTERPRISES BATTERY SET FDA UDI
Identifiers
- Catalog Number
- ME04 FDA UDI
- Primary DI / UDI-DI
- 00653159012105 EUDAMED00653159008429 FDA UDI
- Basic UDI-DI
- 0653159SC0004G9Z EUDAMED
- Direct Marketing DI
- 00653159012105 EUDAMED
- FDA Product Code
- FRG FDA UDIKCT FDA UDI
- EMDN Code
- S010499 STERILISATION CONTAINERS - OTHER EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
Me04 by Case Medical Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0653159SC0004G9Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Case Medical Inc
- EUDAMED SRN
- US-MF-000036357
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 70da7cd5-0f9d-43be-bf30-0b16d1972030 61 fields · synced Jun 18, 2026
- FDA UDI 0ab754c3-16ef-4ebc-9883-74d6d2fdd381 34 fields · synced May 30, 2026