Volumetric Incentive Spirometer 2500ml
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Volumeteric Incentive Spirometer 2500 ml EUDAMEDINCENTIVE SPIROMETER,2500ML FDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- Volumetric Incentive Spirometer 2500ml EUDAMEDIncentive Spirometer (Flow rate) EUDAMED
- Model / Reference
- TB-93250 EUDAMEDFDA UDITB-93100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TB-932502M EUDAMED04716770932507 EUDAMEDFDA UDI
- Basic UDI-DI
- B-TB-932502M EUDAMED4716770TB09300HA EUDAMED
- Direct Marketing DI
- 04716770932507 EUDAMED
- 510(k) Number
- K141355 FDA UDI
- FDA Product Code
- BWF FDA UDI
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
- GMDN Term
- Incentive spirometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5690 FDA UDI
- Market of Registration
- Lithuania EUDAMEDNorthern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Expiratory peak flow meter, digital
Volumetric Incentive Spirometer 2500ml by Besmed Health Business Corp. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Expiratory peak flow meter, digital.
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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-TB-932502M | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-TB-932502M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (3)
- EUDAMED e0beacdb-05d2-4948-9b28-bc8b591f0933 61 fields · synced Aug 3, 2026
- FDA UDI 7fe80037-2123-4b5f-af52-4c41fd8f089e 33 fields · synced May 30, 2026
- EUDAMED ee6ae0c3-7068-42f4-bd1d-34140cca3f07 61 fields · synced Aug 3, 2026