Identity
- Trade Name
- Incentive Spirometer (Flow rate) EUDAMEDINCENTIVE SPIROMETER,600/900/1200ML FDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- Incentive Spirometer (Flow rate) EUDAMED
- Model / Reference
- TB-93100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D-TB-93100ZW EUDAMED04716770931005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-TB-93100ZW EUDAMED4716770TB09300HA EUDAMED
- Direct Marketing DI
- 04716770931005 EUDAMED
- 510(k) Number
- K133873 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
- Germany EUDAMEDCyprus 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
Incentive Spirometer (Flow rate) by Besmed Health Business Corp. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Expiratory peak flow meter, digital.
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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
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-93100ZW | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-TB-93100ZW | 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 c1def392-16a8-4405-b90e-4d671e0292ea 61 fields · synced Jul 17, 2026
- FDA UDI 23d14c05-cd8f-4bdd-b264-33802bb3648d 33 fields · synced May 30, 2026
- EUDAMED 34552ddc-ae49-4eba-9617-9964c3c129a9 61 fields · synced Jul 17, 2026