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Counter Incrementing Dual Spray MiniSpacer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1543A
Identity
- Trade Name
- Counter Incrementing Dual Spray MiniSpacer EUDAMEDMINISPACER FDA UDI
- Generic Name
- Metered dose inhaler FDA UDI
- Device Name
- 15mm OD/ID Dual Spray MiniSpacer with Counter Incrementing Actuator EUDAMEDDUAL SPRAY MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR AND 15MM O.D. X 15MM I.D. CONNECTIONS FDA UDI
- Model / Reference
- 1543A EUDAMEDFDA UDI
- Description
- DUAL SPRAY MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR AND 15MM O.D. X 15MM I.D. CONNECTIONS FDA UDI
Identifiers
- Catalog Number
- 1543A FDA UDI
- Primary DI / UDI-DI
- 00383480000310 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00383480000310 EUDAMED
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Metered dose inhaler FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Straight/elbow breathing circuit connector, reusable
Counter Incrementing Dual Spray MiniSpacer by Thayer Medical Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00383480000310 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Thayer Medical Corporation
- EUDAMED SRN
- US-MF-000026197
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cfd1df48-77e0-43ed-8f42-7d7e50ebd38a 61 fields · synced Jul 10, 2026
- FDA UDI c3c92193-1f0e-41cf-9094-02564a6cf83d 35 fields · synced May 30, 2026