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Anorectal Manometry Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CAT003Model CAT875
Identity
- Trade Name
- Anorectal Manometry Catheter EUDAMEDFDA UDI
- Generic Name
- Urodynamic manometric catheter, non-electronic FDA UDI
- Device Name
- T-DOC Air-Charged Catheter EUDAMEDKateter för Anorektal Tryckmätning FDA UDI
- Model / Reference
- CAT875 EUDAMEDCAT003 EUDAMEDFDA UDI
- Description
- Kateter för Anorektal Tryckmätning FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825001076 EUDAMEDFDA UDI
- Basic UDI-DI
- 062782504NF EUDAMED
- 510(k) Number
- K963064 FDA UDI
- FDA Product Code
- FFX FDA UDI
- EMDN Code
- U050199 CYSTOMANOMETRY AND URETHROMANOMETRY CATHETERS - OTHER EUDAMED
- GMDN Term
- Urodynamic manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Anorectal Manometry Catheter by Laborie Medical Technologies Corp. — Class IIa — 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 | 062782504NF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED ee85c0dc-5d9b-424c-82bd-7bc396108d7d 61 fields · synced Jul 11, 2026
- FDA UDI a00e5c77-8532-44dd-a1b5-a1e85538aa9a 35 fields · synced May 30, 2026