Identity
- Trade Name
- Batrik White Padlock with Indicator FDA UDI
- Generic Name
- Device operating status label/tag, single-use FDA UDI
- Device Name
- Padlock Security Tags EUDAMEDPadlock Security Tags with indicator FDA UDI
- Model / Reference
- 15-901-IND EUDAMEDFDA UDI
- Description
- Padlock Security Tags with indicator FDA UDI
Identifiers
- Catalog Number
- 15-901-IND FDA UDI
- Primary DI / UDI-DI
- 00690521017689 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210PADLOK1000GL EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
- GMDN Term
- Device operating status label/tag, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Austria 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sterilizer/disinfector rack
Padlock Security Tags by Batrik Medical Manufacturing Inc. — Class I — MDR, 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210PADLOK1000GL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 466a4c88-9bf4-4674-9aa2-2421a6a327c7 61 fields · synced Jul 11, 2026
- FDA UDI a231eec7-8543-4f3c-aac7-d69dfd1af0dc 36 fields · synced May 30, 2026