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Dual Limb Insert
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 005525Model Patient circuitsModel Patient circuits (Non-heated)
Identity
- Trade Name
- Dual Limb Insert EUDAMEDDual Limb insert - Paediatric EUDAMEDVivo 65 FDA UDI
- Generic Name
- Mechanical expiratory valve, single-use FDA UDI
- Device Name
- Dual Limb insert - Paediatric EUDAMEDPatient circuits (Non-heated) EUDAMEDDual Limb insert, Paediatric FDA UDI
- Model / Reference
- Patient circuits EUDAMED005525 EUDAMEDFDA UDIPatient circuits (Non-heated) EUDAMED
- Description
- Dual Limb insert, Paediatric FDA UDI
Identifiers
- Catalog Number
- 005525 FDA UDI
- Primary DI / UDI-DI
- 07321820055258 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07321820055258 EUDAMED7321820109998U EUDAMED
- 510(k) Number
- K160481 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- Mechanical expiratory valve, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Dual Limb Insert by Breas Medical AB — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07321820055258 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07321820055258 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (3)
- EUDAMED 74f50f00-6f92-43e2-9bbd-e9212ae67741 61 fields · synced Jul 15, 2026
- EUDAMED 714bff34-be21-4813-86e9-7b4298f066a1 61 fields · synced May 19, 2026
- FDA UDI a3231a87-ece5-4b95-939b-b5584bf143c2 36 fields · synced May 30, 2026