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Perfect Fit 3D Effort Belt
EUDAMEDFDA UDIClass I (EU MDR)
Ref 18-13206-0001Model Perfect Fit 3DRef 11-14001-2501
Identity
- Trade Name
- Perfect Fit 3D Effort Belt EUDAMEDPerfect Fit FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Perfect Fit 3D Effort Belt EUDAMEDPerfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Keyhole FDA UDI
- Model / Reference
- Perfect Fit 3D EUDAMED18-13206-0001 EUDAMEDFDA UDI11-14001-2501 EUDAMED
- Description
- Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Keyhole FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377021824 EUDAMEDFDA UDI10817377020138 EUDAMED
- Basic UDI-DI
- 08173770211450008M EUDAMED
- Direct Marketing DI
- 00817377021824 EUDAMED
- 510(k) Number
- K040605 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Portugal 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
Yes
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
Perfect Fit 3D Effort Belt by Dymedix Diagnostics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Respiratory Effort Belts
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 | 08173770211450008M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED d3316b3c-098a-427f-89aa-506f79664a75 61 fields · synced Jul 9, 2026
- EUDAMED b3ce475d-ae33-4f17-89ae-eebf85f34e35 61 fields · synced May 17, 2026
- FDA UDI b1765f5b-17f4-4906-a0e3-134f8e82f660 34 fields · synced May 30, 2026