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Snugglefit Effort Belt
EUDAMEDFDA UDIClass I (EU MDR)
Ref 12-41115-0001Model Snuggle Fit Effort Belts
Identity
- Trade Name
- Snugglefit Effort Belt EUDAMEDSnuggleFit FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Snuggle Fit EUDAMEDInterface Cable, SnuggleFit, SUM FDA UDI
- Model / Reference
- Snuggle Fit Effort Belts EUDAMED12-41115-0001 EUDAMEDFDA UDI
- Description
- Interface Cable, SnuggleFit, SUM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377022647 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817377021813300AG EUDAMED
- Direct Marketing DI
- 00817377022647 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
Snugglefit 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 | 0817377021813300AG | 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 (2)
- EUDAMED a9f4151f-2ed7-49d9-a57b-6a66d6e1deab 61 fields · synced Jul 9, 2026
- FDA UDI 993ba8b0-823d-41d2-8951-0c85d3a8613f 34 fields · synced May 30, 2026