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ME-050-03-46 ME Dryer
EUDAMEDClass I (EU MDR)
Ref ME-050-03-46Model Nafion Dryer, ME Series
Identity
- Trade Name
- ME-050-03-46 ME Dryer EUDAMED
- Device Name
- Nafion™ Tube Dryer, ME Series EUDAMED
- Model / Reference
- Nafion Dryer, ME Series EUDAMEDME-050-03-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810020360004 EUDAMED
- Basic UDI-DI
- 08401069MESeriesJA EUDAMED
- Direct Marketing DI
- 00810020360004 EUDAMED
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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: Gas-sampling/monitoring respiratory tubing, single-use
ME-050-03-46 ME Dryer by Perma Pure, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gas-sampling/monitoring respiratory tubing, single-use.
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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 | 08401069MESeriesJA | Class I | Active |
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Manufacturer
- Manufacturer
- Perma Pure, LLC
- EUDAMED SRN
- US-MF-000003962
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d90bc792-4242-441e-8a51-c38e7e0273cf 61 fields · synced Jul 31, 2026