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SleepSeal Mouth Tape (external nasal breathing aid)
EUDAMEDClass I (EU MDR)
Ref SS-MT-B-30-wNOHOLEModel SS-MT-B-30-wHOLE, SS-MT-B-30-wNOHOLE, SS-MT-P-30-wHOLE, SS-MT-P-30-wNOHOLE
Identity
- Device Name
- SleepSeal Mouth Tape (external nasal breathing aid) EUDAMED
- Model / Reference
- SS-MT-B-30-wHOLE, SS-MT-B-30-wNOHOLE, SS-MT-P-30-wHOLE, SS-MT-P-30-wNOHOLE EUDAMEDSS-MT-B-30-wNOHOLE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065022182092 EUDAMED
- Basic UDI-DI
- 5065022182tapeAW EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Device sterilization/disinfection container, reusable
SleepSeal Mouth Tape (external nasal breathing aid) by Whiteoak Enterprises Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5065022182tapeAW | Class I | Active |
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Manufacturer
- Manufacturer
- Whiteoak Enterprises Ltd
- EUDAMED SRN
- UK-MF-000053225
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 56c443b6-49dd-4b1e-996c-49ac4a4dd9a4 61 fields · synced Jun 19, 2026