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Perfect Fit 3D Effort Belt
EUDAMEDClass I (EU MDR)
Ref 11-45016-0001Model Perfect Fit 3D
Identity
- Trade Name
- Perfect Fit 3D Effort Belt EUDAMED
- Device Name
- Perfect Fit 3D Effort Belt EUDAMED
- Model / Reference
- Perfect Fit 3D EUDAMED11-45016-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817377023774 EUDAMED
- Basic UDI-DI
- 08173770211450008M EUDAMED
- Direct Marketing DI
- 00817377023774 EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Perfect Fit 3D Effort Belt by Dymedix Diagnostics, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Respiratory Effort Belts
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 | 08173770211450008M | Class I | Active |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED b8d9b849-26df-4091-a6d7-98348e420620 61 fields · synced Jun 18, 2026