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Awl, without Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref TEA212503
by Joimax GmbH
Identity
- Trade Name
- Awl, without Handle EUDAMEDAwl FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Awl, without Handle EUDAMEDFDA UDIAwl EUDAMED
- Model / Reference
- TEA212503 EUDAMEDFDA UDI
- Description
- Awl, without Handle FDA UDI
Identifiers
- Catalog Number
- TEA212503 FDA UDI
- Primary DI / UDI-DI
- 04250337109877 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337109877 EUDAMED42503371AWLAWLD6 EUDAMED
- FDA Product Code
- HWJ FDA UDI
- EMDN Code
- L1113 NEUROSURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Awl, without Handle by Joimax GmbH — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337109877 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337109877 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 00b37d5f-eb9f-4fbc-85ac-4aae0ae4280a 61 fields · synced Jul 17, 2026
- EUDAMED 0a9b5367-dd99-4916-a21d-b0ee36ec6dd9 61 fields · synced May 17, 2026
- FDA UDI 1b4a968d-2d5e-4792-9e06-fb7db8905802 36 fields · synced May 30, 2026