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CapnoPen®
EUDAMEDClass IIb (EU MDR)
Ref CapnoPen® Sterile Endoscopic Nebulizer for Single UseModel CP-001L
Identity
- Trade Name
- CapnoPen® EUDAMED
- Device Name
- CapnoPen® Sterile Endoscopic Nebulizer for Single Use EUDAMED
- Model / Reference
- CP-001L EUDAMEDCapnoPen® Sterile Endoscopic Nebulizer for Single Use EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262397330009 EUDAMED
- Basic UDI-DI
- 426239733CP-001kYK EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue morcellation system handpiece, line-powered
CapnoPen® by Capnopharm GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue morcellation system handpiece, line-powered.
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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 | 426239733CP-001kYK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Capnopharm GmbH
- EUDAMED SRN
- DE-MF-000033336
Sources (1)
- EUDAMED 10d65bd7-3367-44f1-9a1b-eccf30da095b 61 fields · synced Jul 15, 2026