Non sterile: Adult Diaper
by Samela, Inc. d/b/a NorthShore Care Supply 24 variants
Ref 2667Model MEGAMAX Tab-Style Diaper (SKU #’s 1268, 1271, 1274, 1277, 1280, 1283,1286, 1289, 1292, 1601, 1604, 1607,1610, 1613, 1616, 1619, 1622, 1625,1628, 1631 & 1634). etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0193183AdultDiaper01MC 00193183002012 | Date17 Mar 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Non sterile: Adult Diaper
- Model / Reference
- MEGAMAX Tab-Style Diaper (SKU #’s 1268, 1271, 1274, 1277, 1280, 1283, 1286, 1289, 1292, 1601, 1604, 1607, 1610, 1613, 1616, 1619, 1622, 1625, 1628, 1631 & 1634). etc, 2667
- Primary DI / UDI-DI
- 00193183002012
- Basic UDI-DI
- 0193183AdultDiaper01MC
- EMDN Code
- Y0999 Personal care aids - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000046519
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No