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Hunter Sterile Pasteur Bulb
EUDAMEDClass I (EU MDR)
Ref HPB-100
by Promepla SAM
Identity
- Device Name
- Hunter Sterile Pasteur Bulb EUDAMED
- Model / Reference
- HPB-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700512926450 EUDAMED
- Basic UDI-DI
- 037005129GYN02WD EUDAMED
- EMDN Code
- U08020380 DEVICES FOR MICROMANIPULATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Hunter Sterile Pasteur Bulb by Promepla SAM — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 037005129GYN02WD | Class I | Active |
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Manufacturer
- Manufacturer
- Promepla SAM
- EUDAMED SRN
- MC-MF-000015769
- Authorised Representative
- Promepla Group S.à r.l. LU-AR-000013458
Sources (1)
- EUDAMED 8ba15f82-e488-49bf-9e5f-171b59b92f2e 61 fields · synced Jul 9, 2026