Identity
- Trade Name
- DuploSpray MIS EUDAMEDDuplospray FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- Regulator EUDAMEDDUPLOSPRAY MIS REGULATOR 1.5 BAR B11 FDA UDI
- Model / Reference
- 0600134 EUDAMEDFDA UDI
- Description
- DUPLOSPRAY MIS REGULATOR 1.5 BAR B11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634020856 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815634020856 EUDAMED
- FDA Product Code
- CAN FDA UDI
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2700 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DuploSpray MIS by Micromedics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00815634020856 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 98c22fdb-2977-4449-bcf1-0b7931d77bdb 61 fields · synced Jun 20, 2026
- FDA UDI 1df208fb-bf3e-4f78-8bd4-7ed3f557901e 33 fields · synced May 30, 2026