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T piece Infant Resuscitation System
EUDAMEDClass IIb (EU MDR)
Ref BQ70Ref BQ70A
Identity
- Trade Name
- T piece Infant Resuscitation System EUDAMED
- Device Name
- T piece Infant Resuscitation System EUDAMED
- Model / Reference
- BQ70 EUDAMEDBQ70A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020991 EUDAMED06945429021004 EUDAMED
- Basic UDI-DI
- B-06945429020991 EUDAMEDB-06945429021004 EUDAMED
- EMDN Code
- R0599 RESPIRATORY DEVICES, SUCTION AND DILATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
T piece Infant Resuscitation System by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06945429020991 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED a63db777-19aa-4672-a194-e037501a212b 61 fields · synced Oct 6, 2026
- EUDAMED fc311275-ebc3-48da-8a8d-643ad660c4c5 61 fields · synced May 18, 2026