Identity
- Trade Name
- Amnicators FDA UDI
- Generic Name
- Amniotic fluid leak detection device IVD FDA UDI
- Device Name
- Amnicator EUDAMEDAmniotic Fluid Indicator FDA UDI
- Model / Reference
- MWAM5 EUDAMEDN/a FDA UDI
- Description
- Amniotic Fluid Indicator FDA UDI
Identifiers
- Catalog Number
- MWAM5 FDA UDI
- Primary DI / UDI-DI
- 05060259071300 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060259071300 EUDAMED
- FDA Product Code
- HIO FDA UDI
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
- GMDN Term
- Amniotic fluid leak detection device IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.1550 FDA UDI
- Market of Registration
- Germany 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
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose absorbent tip applicator/swab, single-use
Amnicator by Medical Wire & Equipment Co Bath (Ltd) — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-05060259071300 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medical Wire & Equipment Co Bath (Ltd)
- EUDAMED SRN
- GB-MF-000006736
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 62d2b252-07aa-49b4-86e5-4097c4bfc197 61 fields · synced Jul 8, 2026
- FDA UDI 74fb8dd0-28af-4d09-b92b-1e0de84d0045 35 fields · synced May 30, 2026