Identity
- Trade Name
- Resistex EUDAMEDFDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- Resistex EUDAMED
- Model / Reference
- 10-37000 EUDAMED10-37001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043370018 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043RENJ EUDAMED
- 510(k) Number
- K942919 FDA UDI
- FDA Product Code
- BWF FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- Incentive spirometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5690 FDA UDI
- Market of Registration
- Netherlands 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
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Resistex by Mercury Medical — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0641043RENJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1335155f-e661-41eb-a742-a80de270d566 61 fields · synced Oct 6, 2026
- FDA UDI 11bedcce-9a47-49a1-a2a2-93cd8822edcd 34 fields · synced May 30, 2026