Identity
- Trade Name
- Batrik Orange Padlock Security Tags FDA UDI
- Generic Name
- Device operating status label/tag, single-use FDA UDI
- Device Name
- Padlock Security Tags EUDAMEDPadlock Security Tags, Double Locking Hooks, Regular, Orange FDA UDI
- Model / Reference
- 15-770 EUDAMEDFDA UDI
- Description
- Padlock Security Tags, Double Locking Hooks, Regular, Orange FDA UDI
Identifiers
- Catalog Number
- 15-770 FDA UDI
- Primary DI / UDI-DI
- 00690521005433 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
Padlock Security Tags by Batrik Medical Manufacturing Inc. — 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 | 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 547a3004-a0d0-4524-af3d-f5f436f922c1 61 fields · synced Jun 6, 2026
- FDA UDI 7fcb2b16-100e-4304-9f9d-4657eb465a8d 36 fields · synced May 30, 2026