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2 in 1 Muffled Adapter, Molded
EUDAMEDClass I (EU MDR)
Ref R219P50-100
by Maxtec, LLC
Identity
- Trade Name
- 2 in 1 Muffled Adapter, Molded EUDAMED
- Device Name
- 2-in-1 Muffled Adapter EUDAMED
- Model / Reference
- R219P50-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817770021544 EUDAMED
- Basic UDI-DI
- 0817770022IN1ADAPTERHJ EUDAMED
- Direct Marketing DI
- 00817770021544 EUDAMED
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER 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
2 in 1 Muffled Adapter, Molded by Maxtec, Inc. — 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 | 0817770022IN1ADAPTERHJ | Class I | Active |
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Manufacturer
- Manufacturer
- Maxtec, LLC
- EUDAMED SRN
- US-MF-000003961
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 79530785-d3c2-4b11-aeef-4eecdeba4764 61 fields · synced Jul 10, 2026