Ectocare
by PolarSeal Tapes and Conversions Ltd 6 variants
Ref 332-100Model 332-100 Manuka Foam Air 10.2x10.2cm
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05060419550294 05060419550294 | Date4 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- 332-100 Manuka Foam Air 10.2x10.2cm
- Model / Reference
- 332-100 Manuka Foam Air 10.2x10.2cm, 332-100
- Primary DI / UDI-DI
- 05060419550294
- Basic UDI-DI
- B-05060419550294
- EMDN Code
- M040204 Non-adherent absorbent dressings
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000029062
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
Other devices from Polarseal Tapes and Conversions
Properties
Other properties (10)
- 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