Identity
- Trade Name
- HORN PUFF EUDAMED
- Device Name
- Infant T-piece Resuscitator EUDAMEDInfant T-piece Resuscitator with Accessories EUDAMED
- Model / Reference
- nice 5020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989242 EUDAMED
- Basic UDI-DI
- B-08908003989242 EUDAMED08908003989Hornpuff54 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMEDR03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Category: Pulmonary function analysis system, adult
Horn Puff by nice Neotech Medical Systems Pvt. Ltd., — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08908003989242 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08908003989242 | Class IIb | Active |
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Manufacturer
- Manufacturer
- nice Neotech Medical Systems Pvt. Ltd.,
- EUDAMED SRN
- IN-MF-000010243
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (2)
- EUDAMED ec59506d-b563-446e-9273-ecf3325bc2b7 61 fields · synced Jul 15, 2026
- EUDAMED 8b871919-55b8-4b7c-a050-178b7d75ad32 61 fields · synced May 17, 2026