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SP Connector, 22/15mm, 15M, Luer
EUDAMEDClass IIa (EU MDR)
Ref AC0196Ref AC0063Ref AC0064Ref AC0077
Identity
- Trade Name
- SP Connector, 22/15mm, 15M, Luer EUDAMED
- Device Name
- Disposable Connector EUDAMED
- Model / Reference
- AC0196 EUDAMEDAC0063 EUDAMEDAC0064 EUDAMEDAC0077 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980107931 EUDAMED06923980107467 EUDAMED06923980107474 EUDAMED06923980107504 EUDAMED
- Basic UDI-DI
- 69239801ND2GANY EUDAMED
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMEDFinland 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: Straight/elbow breathing circuit connector, reusable
SP Connector, 22/15mm, 15M, Luer by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69239801ND2GANY | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED bbeaf4fe-6444-41e6-8ba0-109c727438ff 61 fields · synced Jul 21, 2026
- EUDAMED b41685c3-3192-4caf-afd6-b3048ed8e6be 61 fields · synced May 17, 2026
- EUDAMED 63a16b44-d05b-4164-8cf3-50c538c51c9f 61 fields · synced May 18, 2026
- EUDAMED 9a3d53f9-8430-4283-840f-10669c4db626 61 fields · synced May 19, 2026